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1 PHYSICIAN LABELING Rx only Device Description The Bausch & Lomb Crystalens Accommodating Posterior Chamber Intraocular Lens is a modified plate haptic lens with hinges across the plates adjacent to the optic. Indications for Use The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. The Crystalens provides approximately one dioptre of monocular accommodation with greater presbyopic spectacle independence for intermediate and near distances. Warnings 1. Some patients may still require glasses to perform certain tasks. 2. There is no clinical data to support placing this lens in the ciliary sulcus. 3. The safety and effectiveness of this lens have not been evaluated in patients under 50 years of age. 4. The effect of vitrectomy on accommodation is unknown. 5. Small amounts of lens decentration occurring with an IOL having a narrow or small optic (< 5.5 mm) may cause glare or other visual disturbances under certain lighting conditions. Surgeons should consider this potential complication before implanting an IOL with a small or narrow optic. 6. YAG-laser posterior capsulotomies should be delayed until at least 12 weeks after the implant surgery. The posterior capsulotomy opening should be limited to no more than 4 mm. Consistent with other IOLS, there is an increased risk of lens dislocation and/or secondary surgical reintervention with early or large YAG capsulotomies. 7. The Crystalens should not be implanted if the capsular bag is not intact or if there is any zonular rupture. 8. The safety and effectiveness of the device has not been established in patients with the following ocular conditions: a. chronic drug miosis E Page 1 of 11

2 b. Amblyopia c. diabetic retinopathy d. previous corneal transplant e. history of retinal detachment f. congenital bilateral cataracts g. Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye. h. Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat posterior segment diseases. i. Surgical difficulties at the time of intraocular lens implantation which might increase the potential for complications (e.g., persistent bleeding, significant vitreous prolapse or loss). j. Corneal endothelial dystrophy. k. Pseudoexfoliation syndrome. l. Suspected microbial infection. 9. Surgeons considering lens implantation in such patients should explore the potential risk/benefit ratio. 10. Mechanical hinge testing has been evaluated in a laboratory setting. Hinge movements of 1,000,000 cycles at 10 cycles per second have been documented with no degradation of hinge integrity or stability. However, long-term stability in the human eye has not been established. Therefore, surgeons should continue to monitor implant patients postoperatively on a regular basis. 11. The effectiveness of ultraviolet light absorbing lenses in reducing the incidence of retinal disorders has not been established. This lens does not significantly absorb light in the ultraviolet region. Patients should be informed that they should wear sunglasses with UV400 protection when in sunlight. 12. The rate of cystoid macular edema may increase with sulcus-bag placement of the haptics. Precautions 1. Do not resterilize this intraocular lens by any method (See Returned Lens Policy). 2. Do not store lenses at temperatures over 45 C (113 F). 3. Do not implant this lens in the anterior chamber. 4. The Crystalens will center automatically at the end of surgery. The optic should be vaulted backward to a position corresponding to the normal location of the posterior capsule. Attempts to position the lens further posteriorly by hyper-inflating the globe with BSS could lead to hyperopic outcomes and should be avoided. 5. A wound leak could cause forward vaulting of the optic. Therefore a scleral tunnel or long multiplane limbal/corneal incision is recommended with a long narrow paracentesis. These incisions are less likely to require suturing, which could cause astigmatism and reduce the postoperative uncorrected vision E Page 2 of 11

3 Adverse Events The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control ( FDA grid ) population (see Table 1). As with any surgical procedure, risk is involved. Potential adverse events accompanying cataract or implant surgery may include, but are not limited to, the following: lens subluxation, corneal endothelial damage, non-pigment precipitates, cystoid macular edema, infection, retinal detachment, vitreous loss, pupillary block, secondary glaucoma, iris prolapse, vitreous-wick syndrome, uveitis, and pupillary membrane. Stability The stability of the outcomes was demonstrated in a consistent cohort of patients across 1-2 months to 3-6 months and 3-6 months to months postoperative intervals. Stability was measured using both the manifest spherical equivalent (MRSE) and visual acuity. Clinical Trials In a substudy of 185 subjects comparing the Crystalens with a control population comprised of several models of standard IOLs*, the visual acuity at all distances at 3-6 months postoperative was significantly greater in Crystalens implanted eyes than in eyes implanted with a standard IOL. The results are shown in Table 2. A clinical trial of the model AT-45-HD100 consisting of 216 subjects followed for 4-6 months was conducted. In Table 3, the visual acuity results are compared to the parent Model AT-45. * Several models of standard IOLs of varying types (e.g., single piece, multipiece) and materials are listed in Table 4 Detailed Device Description Lens Optic Material: Silicone Elastomer (Biosil ) Light transmittance: 95% ( 5%) in the visible region of the light spectrum ( nm). UV cut-offs at 10% T for a +4 diopter lens (thinnest) and a +34 diopter lens (thickest) occurs at nm as shown in Figure 1 Index of refraction: (35 C) Crystalens Five-0 Model AT-50SE Diopter power: +17 to +27 diopters in 0.25 diopter increments, and +27 to +33 diopters in 0.5 diopter increments. Crystalens Five-0 Model AT-52SE Diopter power: +4 to +10 diopters in 1.0 diopter increments, +10 to +16 diopters in 0.5 diopter increments, and +16 to diopters in 0.25 diopter increments E Page 3 of 11

4 Crystalens HD Model HD500 Diopter power: +17 to +33 diopters in 0.5 diopter increments. Crystalens HD Model HD520 Diopter power: +10 to diopters in 0.5 diopter increments. Haptics The plate haptics have hinges across the face of the plates adjacent to the optic. Two flexible colored polyimide (Kapton ) loops are attached to each distal extremity of the plates, making the lens 11.5 mm or 12.0mm in overall length. The length of the plate is 10.5 mm. Mechanism of action The Crystalens was designed to move in a backward and forward motion along the axis of the eye in response to pressure changes in the vitreous cavity and anterior chamber that result from relaxation and contraction of the ciliary muscle. The exact mechanism of action has not been fully elucidated. Directions for Use 1. Prior to implanting, examine the lens package for IOL type, power, and expiration date. 2. Open the peel pouch and remove the lens from the sterile packaging by pressing and lifting the cover off the plastic lens case (holder). Place the lens in a sterile environment. 3. Examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surface for other defects. 4. Position the lower blade of the forceps in the slot of the lens case beneath the lens. A Cumming intraocular lens forceps is recommended. Grasp the lens so that the forceps extends across the distal hinge to stabilize the leading plate haptic. Do not grasp the lens by the haptics. 5. Remove the lens in its position for implantation with a single grasp. 6. Advance the forceps to place the leading plate haptic of the lens into the distal capsular bag, which should be completely filled with a cohesive viscoelastic. 7. The round knob on the loop of the leading haptic should be on the right to ensure that the hinge s open side is right side up and is facing the anterior part of the eye on implantation. 8. With a second instrument, hold the proximal polyimide loop to maintain the position of the lens in the capsular bag as the implantation forceps are withdrawn from the eye. 9. Regrasp at the tip of the trailing plate haptic with the implantation forceps. 10. As you advance the trailing plate haptic into the anterior chamber, the polyimide loops will bend back on themselves as they traverse the small incision. Advance the leading plate up towards the cornea. This will E Page 4 of 11

5 cause the leading plate haptic to bend to a right angle deep into the bag. 11. Maintain your grasp at the tip of the trailing plate haptic. Tuck the polyimide loops, one by one, into the capsular bag. Do not release the tip until the loops are in the bag. 12. Release and withdraw the forceps. The lens will self-center. 13. Please refer to the addendum supplied with each lens model for more detailed information on the use of injectors with the Crystalens. NOTE: The lens may pick up an electrostatic charge upon opening the package. The lens should be carefully examined to ensure that particles have not been attracted to its surface. The Crystalsert delivery system or the Staar MSI-TR, MSI-PR, MSI-TF or MSI-PF injector, in conjunction with the Staar MTC-60c cartridge, may be used to inject the Crystalens. A cohesive viscoelastic should be used for lubrication of the injector when inserting the IOL. The IOL should be injected within three minutes after loading. Refer to the instructions for use supplied with the injector. See for further details on the use of the injector with the Crystalens. Lens Power Calculations The surgeon should determine preoperatively the power of the lens to be implanted by using either immersion or IOL Master biometry and manual keratometry. Lens power calculation methods are described in the following references: Holladay JT et al. A Three Part System for Refining Intraocular Lens Power Calculations. J Cataract Surg 14, January Retzlaff JA et al. Development of the SRK/T intraocular lens implant power calculation formula. J Cataract Refract Surg 16, May Hoffer KJ. The Hoffer Q Formula. A comparison of theoretical and regression formulas. J Cataract Refract Surg 19, November NOTE: The Surgeon Factor, A Constant and ACD values, which are located on the outside of the package, are estimates only. It is recommended that the surgeon determine his/her own values based on their individual clinical experience. Surgeons requiring additional information on lens power calculation may contact Bausch & Lomb. Recommendations for Maximizing Patient Outcomes Manual keratometry, immersion biometry or interferometry is strongly recommended to obtain optimum patient outcomes. The first eye implant should be targeted for between 0.25 and diopter and the second eye implant targeted for plano. In any case, E Page 5 of 11

6 the outcome of the second eye implant should be determined based on the outcome of the first eye. A waiting period of two weeks between the first and second eye is recommended in order to accurately determine the lens power for the second eye. Incision width should be 3.5 to 3.7 mm but no larger than 4 mm and should be at least 2.5 mm long. The paracentesis should be approximately 1.0 to 1.5 mm in width and approximately 2.0 mm long. The capsulorhexis should be round (5.5 to 6.0 mm) with the anterior capsule covering the plate haptics. If the capsulorhexis is oval, then the lens should be rotated to ensure maximum coverage of the plate haptics. Meticulous cortical clean-up should be performed and the lens rotated at least 90º to dislodge any hidden or trapped cortex. Patients should be kept on a tapering course of anti-inflammatory agents for a minimum of 4 weeks. Patient Registration Instructions and Reporting Registration Each patient who receives a Crystalens must be registered with Bausch & Lomb at the time of lens implantation. Registration is accomplished by completing the Implant Registration Card that is enclosed in the lens package and mailing it to Bausch & Lomb. Patient registration is essential and will assist Bausch & Lomb in responding to adverse reaction reports and/or potentially sight-threatening complications. An implant identification card is supplied in the lens package and must be given to the patient. Reporting Adverse Reactions and/or potentially sight-threatening complications that may reasonably be regarded as lens related and that were not previously expected in nature, severity or degree of incidence should be reported to Bausch & Lomb at (USA). This information is being requested from all surgeons in order to document potential long-term effects of intraocular lens implantation. How Supplied The contents of the inner and outer peel pouches are sterile unless the packages are damaged or opened. The intraocular lenses are moist heat sterilized and supplied in a lens case within a double aseptic transfer peel pouch. The contents of the inner and outer peel pouches are sterile unless the packages are damaged or opened. Expiration Date Sterility is guaranteed unless the sterile pouch is damaged or opened. In addition, there is a sterility expiration date that is clearly indicated on the outside of the package. The lens should not be used after the indicated date E Page 6 of 11

7 Returned Lens Policy Please contact your local Bausch & Lomb office regarding lens exchange. Bibliography 1. Boettner, EA and Wolter JR Transmission of the ocular media. Invest Ophthal 1: Busacca, A. La Physiologie Du Muscle Ciliaire Etudiee Par La Gonioscopie. Annales D Oculistique 1955; Coleman J. On the hydraulic suspension theory of accommodation. Trans Am Ophth Soc 1986; Colin, J. Clinical results of implanting a silicone haptic-anchor-plate intraocular lens. J Cataract Refract Surg, 1996;2: Cumming JS et al. Clinical evaluation of the Model AT-45 silicone accommodating intraocular lens. Ophthalmology 2001;108: Cumming JS, Ritter J. The Measurement of Vitreous Cavity Length and its Comparison Pre- and Postoperatively. Eur J Implant Ref Surg 1994;6: Fisher R. The ciliary body in accommodation. Tran Ophthalmol Soc UK 1986;105: Girard LJ et al. Complications of the Simcoe Flexible Loop Phacoprosthesis in the anterior chamber. Ophthalmic Surg 14(4) 9. Glasser A and Kaufman PL. The mechanism of accommodation in primates. Ophthalmol 1999;106: Kammann J. Vitreous-stabilizing, single-piece, mini-loop, platehaptic silicone intraocular lens. J Cataract Refract Surg 1998;24: Thornton S. Accommodation in pseudophakia. Color Atlas of Lens Implantation. 1991; Willis DA, Stewart RH, Kimbrough RL. Pupillary block associated with posterior chamber lenses. Ophthalmic Surg 1985; 16: E Page 7 of 11

8 Table 1 Adverse Events Reported at 12 months Adverse Event Cumulative FDA Grid* Persistent FDA Grid Primary All Eyes Primary All Eyes Eyes Eyes Endophthalmitis 1/324 1/497 4/ (0.3%) (0.2%) (0.1%) Hyphema 1/324 1/497 91/ (0.3%) (0.2%) (2.2%) Hypopyon 0/324 0/497 16/ (0.3%) IOL Dislocation 0/324 0/497 5/ (0.1%) Cystoid Macular Edema 12/324 (3.7%) 13/497 (2.6%) 124/4219 (3.0%) 2/304 (0.7%) 3/450 (0.7%) 19/4219 (0.5%) Pupillary Block 0/324 0/497 5/ (0.1%) Retinal 0/324 0/497 11/ Detachment (0.3%) Secondary 2/324 4/497 46/ Surgical Reintervention (0.6%) (0.8%) (0.8%) Corneal Edema /298 0/440 11/4219 (0.3%) Iritis /298 (0.7%) 3/440 (0.7%) 11/4219 (0.3%) Raised IOP Requiring Treatment /304 0/450 17/4219 (0.4%) *Guidance for Industry and for FDA Reviewers Intraocular Lens Guidance Document Table 2 Crystalens vs Standard IOL Visual Acuity (Best Spectacle Corrected Distance and Near and Intermediate Acuity Through the Distance Correction, 3 to 6 months postoperatively) Crystalens Standard IOL 20/20 or better 1/ % 0/64 0.0% 20/25 or better 29/ % 0/64 0.0% 20/32 or better 61/ % 3/64 4.7% 20/40 or better 107/ % 23/ % Worse than 20/40 14/ % 41/ % E Page 8 of 11

9 Table 3 Summary of Effectiveness at 4-6 Month Follow-up Primary Eyes (within 0.50D of target refraction) HD100 Model AT-45 EFFECTIVENESS 20/40 or better 20/40 or better VISUAL ACUITY (VA) N = 67 N = 149 Near Uncorrected (UNVA) 89.6% 89.3% Intermediate Uncorrected (UNVA) 100.0% Not recorded Distance Uncorrected (UNVA) 95.5% 87.9% E Page 9 of 11

10 Table 4 Summary of Standard IOLs Used in the Trial* Manufacturer Model/Name Design Material Number of lenses implanted Pharmacia 911A Cee-On Multipiece Silicone 7 Pharmacia 812 Cee-On Single piece PMMA 2 Pharmacia 920 Cee-On Multipiece Silicone 23 optic/pmma haptics Pharmacia 913A Multipiece PVDF 4 STAAR CC4204BF Single piece Silicone 1 STAAR AQ2010V Multipiece Silicone 3 optic/polyimide loops STAAR NA NA NA 2** AMO/Allergan SI30NB/PhacoFlex Multipiece Silicone optic/polypropylen 1 e haptics AMO/Allergan SI40NB/PhacoFlex Multipiece Silicone 5 optic/pmma haptics AMO/Allergan AR40e/Sensar Multipiece Acrylic optic/pmma 3 haptics Alcon SA30AL/Acrysof Single piece Acrylate/Methacryl 4 ate Copolymer Alcon SA60AT/Acrysof Multipiece Acrylate/Methacryl 9 ate Copolymer Medennium 400 Multipiece Hydrophobic acrylic/pvdf haptics 1 *Cumming JS et al., Clinical evaluation of the Crystalens AT-45 accommodating intraocular lens: Results of the U.S. Food and Drug Administration clinical trial. J Cataract Refract Surg 2006; 32: **One subject did not have contrast sensitivity data so is not included in the total E Page 10 of 11

11 SYMBOL ENGLISH MANUFACTURE DATE (MM-YY: month-year) DO NOT REUSE USE BY (MM-YY: month-year) SEE INSTRUCTIONS FOR USE STERILIZED BY STEAM Manufactured in the USA by Bausch & Lomb Incorporated, Aliso Viejo, CA USA (866) EU Authorized Representative: Bausch & Lomb Incorporated, 106 London Road, Kingston-Upon-Thames, KT2 6TN, UK E Page 11 of 11

12 博士倫 " 晶鑽調節式人工水晶體 Bausch & Lomb"Crystalens Accommodating Intraocular Lens 衛署醫器輸字第 號 產品說明本產品是經過改良的可調節型後房人工晶體, 晶體兩邊各有一個晶板, 晶板上各有鏡腳 型號 AT-50SE AT-52SE HD500 HD520 Optic diameter 5.0 mm 5.0 mm 5.0 mm 5.0 mm Optic shape Biconvex w/360 o square edge Biconvex w/360 o square edge Enhanced Accommodative optic w/360 o square edge Enhanced Accommodative optic w/360 o square edge Haptic angulation 0 o 0 o 0 o 0 o A Constant Refractive index Overall length 11.5 mm 12.0 mm 11.5 mm 12.0 mm Power range D D D D 適應症 Crystalens 是用來植入眼睛的囊袋中, 以矯正有 無老花眼之成人患者摘除白內障後所產生的晶體缺乏 Crystalens 提供患者大約 100 度單眼調節力, 可降低患者中, 近距離對老花眼鏡的依賴 警告 1. 某些患者可能仍需要眼鏡來進行特定活動 2. 目前並無臨床資料支持將 Crystalens 植入睫狀溝內 3. 對 50 歲以下的患者, 尚未評估 Crystalens 的安全與有效性 4. 目前摘除玻璃體對眼睛調節力的影響尚未明瞭 5. 晶體光學區較小的人工水晶體在稍微偏位及特定照明狀況中可能造成反光或其他視覺干擾 在植入晶體窄小的 IOL 之前, 執刀醫師應思考可能的併發症 6. 植入 Crystalens 後, 應等待至少 12 個星期才能進行 YAG- 雷射後囊切開術 後囊切開術的切口不可大於 4mm 如同其他 IOL, 過早執行 YAG 切開術或 YAG 後囊體切開術的切口過大, 將會大大提高晶體移位及 ( 或 ) 再次手術介入的可能性 7. 患者的囊袋如異常 不完整, 或有小帶破裂等, 則不可植入 Crystalens 8. 對下列狀況的患者, 目前尚未確定 Crystalens 的安全與有效性 : a. 慢性藥物瞳孔縮小 b. 弱視 c. 糖尿病所引發的視網膜病 d. 曾接受角膜移植 e. 曾視網膜剝離 f. 先天雙眼白內障 g. 不明原因的再發性眼睛前部或後部發炎, 或因為疾病而造成眼睛產生發炎反應 h. 晶體的存在可能干擾對患者進行眼睛後部眼疾的觀察 診斷或治療 1

13 i. 晶體植入手術的困難性, 可能提高併發症的風險 ( 例如, 無法止血 嚴重的玻璃體脫出 ) j. 角膜內皮失養症 k. 假性剝落症狀 l. 可疑性微生物感染 9. 執刀醫師應思考在這類患者植入 Crystalens 的優缺利弊與風險 10. 已在實驗室對晶鏈進行機械測試與評估 目前已有文件顯示晶鏈每秒運動 10 次, 總計運動 1 百萬次後, 尚未發現晶鏈的穩定性或結構減損 然而, 對晶鏈在人眼中的長期穩定性, 目前尚未驗證 因此, 執刀醫師應在術後繼續定期監看植入 Crystalens 的患者情形 11. 目前尚未驗證抗紫外線晶體是否能夠有效減少視網膜病變 Crystalens 無法顯著隔離紫外線 醫師應告訴患者在陽光中應配戴 UV400 的抗紫外線太陽眼鏡 12. 將晶體置入睫狀溝內可能提高黃班部水腫的可能性 注意事項 1. 禁止使用任何方法再滅菌 Crystalens 2. 請勿將 Crystalens 存放在 45 (113 ) 以上的溫度中 3. 請勿將 Crystalens 植入前房 4. 手術後,Crystalens 會自動呈中心定位 晶體會往後呈拱形, 位置對應後囊的正常位置 若嘗試使用 BSS 過度灌注眼內而讓晶體位在更後面的位置, 有可能產生遠視後果, 應予避免 5. 因傷口洩漏有可能導致晶體往前呈拱形 因此, 建議使用較長的穿刺術進行角膜切開 / 鞏膜隧道切開或狹長多面傷口切開 這些切口比較不需要縫合 縫合可能造成散光, 並減低術後未矯正視力 不良反應臨床實驗中的併發症相當於或低於歷史對照組 ( FDA grid") 中的併發症 ( 請參見表 1) 但任何手術都免不了風險 白內障或植入手術的可能併發症包括以下但不局限於此 : 晶體半脫位 角膜內皮受損 非色素沈澱 黃斑部水腫 感染 視網膜剝離 玻璃體脫出 瞳孔阻斷 繼發性青光眼 虹膜脫出 Vitreous Wick 症候群 葡萄膜炎 瞳孔膜 穩定性術後的穩定性可透過不同術後時期的評量證實 : 比較患者術後 1-2 個月及 3-6 個月間穩定性, 術後 3-6 個月及 個月間穩定性 穩定性的評估是依據驗光球鏡度數 (manifest spherical equivalent, MRSE) 與視力的測量 臨床實驗註一項包括 185 位受試者的附屬研究, 比較了 121 位使用 Crystalens 與 64 位使用標準 IOLs 的術後表現 結果顯示, 術後 3 到 6 個月, 植入 Crystalens 的患者在所有距離的視力皆明顯優於植入標準型 IOL 的患者 試驗結果列於表 2 另一項包括 216 位受試者 進行 4-6 個月追蹤之臨床試驗, 比較了使用 Crystalens model AT-45-HD100 與前一代 AT-45 的術後視力, 請參考表 3 2

14 註 試驗中之標準 IOLs 包含不同款式 ( 例如單一成型 多件組合 ) 與材料 ( 例如矽樹脂 丙烯酸 ), 詳見表 4 詳細產品說明晶體 材質 : 彈性矽樹脂 (Biosil) 透光性 : 在 nm 光譜的可視區, 為 95%±5% 在 nm 中,4 屈光度 ( 最薄 ) 與 34 屈光度 ( 最厚 ) 的晶體的紫外線隔絕度為 10% 折射率 :1.428(35 ) 晶鑽調節式人工水晶體 Model AT-50SE +17 to +27D 以每 0.25D 間隔 +27 to +33D 以每 0.5D 間隔 晶鑽調節式人工水晶體 Model AT-52SE +4 to +10 D 以每 1.0 D 間隔 +10 to +16D 以每 0.5D 間隔 +16 to D 以每 0.25D 間隔 晶鑽調節式人工水晶體 HD to +33D 以每 0.5D 間隔 晶鑽調節式人工水晶體 HD to +16.5D 以每 0.5D 間隔 鏡腳晶體兩邊的晶板表面各有一對鏡腳 晶板的每個末稍各有兩個彈性的有色聚酰亞胺 (Kapton) 圓圈, 讓晶體總長 11.5mm 或 12.0mm 晶板長 10.5mm 作用機轉 Crystalens 的設計是希望在眼球睫狀肌肉伸縮造成前房與玻璃體腔壓力改變時, 鏡片能在視軸線上前後移動 本產品作用機轉尚未明瞭 使用指示 1. 植入之前, 請檢查包裝上的 IOL 型號 度數與保存期限等標示 2. 撕開包裝袋後, 請壓下裝有晶體的塑膠盒, 讓盒蓋打開, 然後小心取出晶體 請將晶體放在無菌環境內 3. 請仔細檢查晶體, 確定未黏附任何異物, 並請檢查晶體表面是否有異常或缺陷 4. 請將鑷子的下方放入晶體下方的晶體盒溝槽 建議使用晶體專用鑷子 使用鑷子夾住晶體, 讓鑷子延伸跨越晶鏈末稍, 以穩定晶板 切勿以夾住鏡腳方式, 取出晶體 5. 以鑷子將晶體以植入位置拿出 6. 將鑷子往前, 將晶板放入末稍囊袋 應使用有黏力與彈性物質填入整個囊袋 3

15 7. 鏡腳上的圓形突出物應位在右邊, 以確保晶鏈的 開口 端呈現 右邊朝上, 且朝向植入眼睛的前部 8. 使用第二個工具握住近側的聚酰亞胺圓圈, 以在鑷子移離眼睛時, 維持晶體在囊袋內的位置 9. 使用鑷子夾住位於尾部的晶板的尖端 10. 當您將尾部的晶板送入前房時, 聚酰亞胺圓圈會在橫越切口時往後彎 將位於頭部的晶板往上朝角膜送入 這會造成位居頭部的晶板以直角深深彎入囊袋內 11. 使用鑷子繼續夾住位於尾部的晶板的尖端 一次一個, 將聚酰亞胺圓圈塞入囊袋 在聚酰亞胺圓圈位在囊袋之前, 不要鬆開尖端 12. 鬆開及抽回鑷子 晶體會自動定於中心位置 13. 關於特定型號的注射器使用資訊, 請參見該型號的附件 註 : 打開包裝後, 晶體可能吸附靜電 應仔細檢查晶體, 確定表面未黏附任何異物 晶體度數計算執刀醫師應在手術前計算所要植入晶體的度數, 可使用 Immersion 或 IOL Master biometry 與人工角膜弧度計 晶體度數計算方法說明於下列文獻中 : Holladay J T et al. A Three Part Tystem for Refining Intraocular Lens Power Calculations. J Cataract Turg 14, January Retzlaff J A et al. Development of the TRK/T intraocular lens implant power calculation formula. J Cataract Refract Turg 16, May HofferK J. The Hoffer Q Formula. A comparison of the oretical and regression formulas. J Cataract Refract Turg 19, November 註 : 包裝外面的 Surgeon Factor 'A' 常數與 ACD 值僅為估計而已 建議醫師依照自己的臨床經驗判斷數值 如需要晶體度數計算的進一步資訊, 可洽詢 Bausch & Lomb 讓患者獲得最佳效益的建議 強烈建議人工角膜弧度測量 浸潤生物測定或干涉測定, 以獲得最佳的術後結果 第一眼植入物應力求 0.25 到 屈光度, 第二眼植入物應力求 0 度 任何情況中, 應依據第一眼的結果來判定第二眼植入物的結果 建議第一眼與第二眼之間應有兩個星期的等待期, 以正確判定第二眼的晶體度數 切口寬度應為 3.5 到 3.7mm, 不超過 4mm, 且應至少 2.5mm 長 穿刺應約為 1.0 到 1.5mm 寬 約 2.0mm 長 囊袋撕開應為圓形 (5.5 到 6.0mm), 且前囊應包覆人工晶體光學區 如果囊袋撕開為卵形, 那麼晶體應旋轉, 以確保人工晶體光學區的最大覆蓋 應謹慎執行水晶體皮質的清除, 且人工晶體應旋轉至少 90 度以清除任何隱藏或卡住的水晶體皮質 患者應接受逐漸減量的消炎劑療程至少 4 星期 患者登記與登記通報植入 Crystalens 的患者應在植入晶體時向 Bausch & Lomb 登記 4

16 登記方式為填寫晶體包裝盒內的植入登記卡, 然後寄回 Bausch & Lomb 患者登記是必要的, 可協助 Bausch & Lomb 回覆術後不利反應報告及 ( 或 ) 潛在的視力威脅併發症 晶體包裝盒內有一張植入識別卡, 務必交給患者 報告跟晶體有關的無預期不利反應及 ( 或 ) 潛在視力威脅併發症, 包括嚴重度或發生率, 應撥打電話 ( 美國 ) 告知 Bausch & Lomb 所有執刀醫師都必須提供這類資訊, 以記錄潛在的長期眼內晶體植入影響 包裝除非包裝受損或開啟, 否則內 外袋內的內容物已經滅菌 眼內晶體經過濕熱滅菌, 裝入一個晶體盒內, 再將晶體盒放入一個雙層無菌袋 除非包裝受損或開啟, 否則內 外袋內的內容物已經滅菌 失效日期除非包裝袋受損或已開啟, 否則擔保晶體無菌 包裝的外側清楚標示滅菌的失效日期 晶體一旦過了失效日期, 即不可使用 產品效期 :5 年 晶體退回政策關於晶體退回交換, 請洽您所在地的 Bausch & Lomb 公司 臺灣通報 - 博士倫股份有限公司台北市市民大道四段 102 號 11 樓 參考文獻 1. Boettner, EA and Walter JR Transmission of the ocular media. Invest Ophthal 1: Busacca, A. La Physiologie Du Muscle Ciliaire Etudiee Par La Gonioscopie. Annales D'Oculistique 1955; Coleman J. On the hydraulic suspension theory of accommodation. Trans Am Ophth Soc 1986; Colin, J. Clinical results of implanting a silicone haptic-anchorplate intraocular lens. J Cataract Refract Surg, 1996;2: Cumming JS et al. Clinical evaluation of the Model AT-45 silicone accommodating intraocular lens. Ophthalmology 2001;108: Cumming JS, Ritter J. The Measurement of Vitreous Cavity Length and its Comparison Pre- and Postoperatively. Eur J Implant Ref Surg 1994;6: Fisher R. The ciliary body in accommodation. Tran Ophthalmol Soc UK 1986;105: Girard LJ et al. Complications of the Simcoe Flexible Loop Phacoprosthesis in the 5

17 anterior chamber. Ophthalmic Surg 14(4) 9. Glasser A and Kaufman PL. The mechanism of accommodation in primates. Ophthalmol 1999;106: Kammann J. Vitreous-stabilizing, single-piece, mini-loop, platehaptic silicone intraocular lens. J Cataract Refract Surg 1998;24: Thornton S. Accommodation in pseudophakia. Color Atlas of Lens Implantation. 1991; Willis DA, Stewart RH, Kimbrough RL. Pupillary block associated with posterior chamber lenses. Ophthalmic Surg 1985; 16:

18 Table 1 Adverse Events Reported at 12 months Adverse Event Cumulative FDA Grid* Persistent FDA Grid Primary All Eyes Primary All Eyes Eyes Eyes Endophthalmitis 1/324 1/497 4/ (0.3%) (0.2%) (0.1%) Hyphema 1/324 1/497 91/ (0.3%) (0.2%) (2.2%) Hypopyon 0/324 0/497 16/ (0.3%) IOL Dislocation 0/324 0/497 5/ (0.1%) Cystoid Macular Edema 12/324 (3.7%) 13/497 (2.6%) 124/4219 (3.0%) 2/304 (0.7%) 3/450 (0.7%) 19/4219 (0.5%) Pupillary Block 0/324 0/497 5/ (0.1%) Retinal 0/324 0/497 11/ Detachment (0.3%) Secondary 2/324 4/497 46/ Surgical Reintervention (0.6%) (0.8%) (0.8%) Corneal Edema /298 0/440 11/4219 (0.3%) Iritis /298 (0.7%) 3/440 (0.7%) 11/4219 (0.3%) Raised IOP Requiring Treatment /304 0/450 17/4219 (0.4%) *Guidance for Industry and for FDA Reviewers Intraocular Lens Guidance Document Table 2 Crystalens vs Standard IOL Visual Acuity (Best Spectacle Corrected Distance and Near and Intermediate Acuity Through the Distance Correction, 3 to 6 months postoperatively) Crystalens Standard IOL 20/20 or better 1/ % 0/64 0.0% 20/25 or better 29/ % 0/64 0.0% 20/32 or better 61/ % 3/64 4.7% 20/40 or better 107/ % 23/ % Worse than 20/40 14/ % 41/ % 7

19 Table 3 Summary of Effectiveness at 4-6 Month Follow-up Primary Eyes (within 0.50D of target refraction) HD100 Model AT-45 EFFECTIVENESS 20/40 or better 20/40 or better VISUAL ACUITY (VA) N = 67 N = 149 Near Uncorrected (UNVA) 89.6% 89.3% Intermediate Uncorrected (UNVA) 100.0% Not recorded Distance Uncorrected (UNVA) 95.5% 87.9% 8

20 Table 4 Summary of Standard IOLs Used in the Trial* Manufacturer Model/Name Design Material Number of lenses implanted Pharmacia 911A Cee-On Multipiece Silicone 7 Pharmacia 812 Cee-On Single piece PMMA 2 Pharmacia 920 Cee-On Multipiece Silicone 23 optic/pmma haptics Pharmacia 913A Multipiece PVDF 4 STAAR CC4204BF Single piece Silicone 1 STAAR AQ2010V Multipiece Silicone 3 optic/polyimide loops STAAR NA NA NA 2** AMO/Allergan SI30NB/PhacoFlex Multipiece Silicone optic/polypropylen 1 e haptics AMO/Allergan SI40NB/PhacoFlex Multipiece Silicone 5 optic/pmma haptics AMO/Allergan AR40e/Sensar Multipiece Acrylic optic/pmma 3 haptics Alcon SA30AL/Acrysof Single piece Acrylate/Methacryl 4 ate Copolymer Alcon SA60AT/Acrysof Multipiece Acrylate/Methacryl 9 ate Copolymer Medennium 400 Multipiece Hydrophobic acrylic/pvdf haptics 1 *Cumming JS et al., Clinical evaluation of the Crystalens AT-45 accommodating intraocular lens: Results of the U.S. Food and Drug Administration clinical trial. J Cataract Refract Surg 2006; 32: ** 其中一位受試者因未能取得對比敏感度資料 (contrast sensitivity data) 而未納入受試者總數 製造廠名稱 :Bausch & Lamb Incorporated 製造廠地址 :10574 Acacia, Suite D-1, Rancho Cucamonga, California 91730, USA 藥商名稱 : 博士倫股份有限公司藥商地址 : 台北市大安區市民大道四段 102 號 11 樓 9

21 製造廠名稱 :Bausch & Lomb Incorporated 製造廠地址 :10574 Acacia, Suite D-1, Rancho Cucamonga, California 91730, USA 藥商名稱 : 博士倫股份有限公司藥商地址 : 臺北市大安區市民大道四段 102 號 11 樓

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