PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses

Transcription

1 PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses ENGLISH PRODUCT INFORMATION

2 PRODUCT INFORMATION ENGLISH Alcon Laboratories, Inc. STERILE UV-Absorbing PMMA Single-Piece Posterior Chamber Lenses Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Model Characteristics Chart Model Optic Type Hole Locations Optic Diameter (mm) Ø B Overall Length Haptic Type Haptic Angle/ Configuration (mm) Ø T CZ70BD B Eyelets Mod-C 5º/SL LX10BD B None Mod-C 5º/SL MC50BD B None Mod-C 5º/SL MZ30BD B None Mod-C 5º/SL MZ40BD B None Mod-C 5º/SL MZ60BD B None Mod-C 5º/SL MZ60MD M None Mod-C 5º/SL MZ60PD P None Mod-C 5º/SL SL - SLANT 1 haptics For implantation in the capsular bag (see INDICATIONS) SLANT 1 Haptics Certain models listed above are footnoted as having SLANT 1 haptics. The following diagrams compare this haptic confi guration with common angulated haptics: Figure 1 1 ANGULATED Haptics SLANT Haptics ANGLE STRAIGHT VAULT CURVED (RADIUS) DESCRIPTION Alcon UV-absorbing PMMA single-piece posterior chamber lenses are optical implants for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients. These lenses have biconvex, convexoplano, meniscus, plano-concave or convexoplano with HOFFER* ridge modifi cation optics with supporting haptics. The physical properties of these lenses are: OPTICS HAPTICS Material: Polymethylmethacrylate (PMMA), Configuration: See MODEL CHARACTERISTICS ultraviolet-absorbing Chart UV cutoff 374 nm ( diopter lens) Material: PMMA (See OPTICS Material) at 10% T: 388 nm (+34.0 diopter lens) Color: Clear Specific Gravity: 1.19 Index of Refraction: 1.49 Configuration: Biconvex, convexoplano, meniscus, plano-concave and convexoplano with HOFFER* ridge modifi cation Power: +4.0 diopter through diopter (MZ60MD/+3.0 diopter through -3.0 diopter) (MZ60PD/-4.0 diopter through diopter) 1 Reg. U.S. Pat. & TM Off. * HOFFER Reg. TM of Ridge Lens Corp. -2-

3 SPECTRAL TRANSMITTANCE CURVES (PERCENTAGE OF ULTRAVIOLET TRANSMITTANCE) Figure NOTES: The cutoff wavelength and the spectral transmittance curves presented here represent the range of transmittance values of IOLs made from ultraviolet-absorbing PMMA. Measurements were direct transmittance using a disc of thickness equivalent to the optic center. UV cutoff at 10% T is 374 nm (-10.0 diopter lens). UV cutoff at 10% T is 388 nm (+34.0 diopter lens). Human lens data from Boettner and Wolter (1962). TRANSMITTANCE (%) WAVELENGTH (nm) MODE OF ACTION These posterior chamber intraocular lenses are intended to be positioned only in the posterior chamber of the eye. INDICATIONS These posterior chamber intraocular lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. Many of these lenses are intended for placement in either the capsular bag or the ciliary sulcus. Lens models LX10BD, MZ40BD, MZ60MD and MZ60PD are intended for placement in the capsular bag. The surgeon should consider both overall length and optic diameter (see MODEL CHARACTERISTICS Chart) as well as the individual patient s physiology and needs in determining optimal placement for a specifi c lens model. CAUTION Special consideration should be given to the dimensions of lens Models MZ60MD and MZ60PD at the extreme ends of the power range in relation to the anatomical clearances in the patient s eye. The potential impact of factors such as optic central thickness, optic edge thickness and overall lens size on a patient s long-term clinical outcome must be carefully weighed against the potential benefi t associated with the implantation of an intraocular lens. The patient s clinical progress should be carefully monitored. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with the treatment of a condition, or may pose an unreasonable risk to the patient s eyesight. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefi t/risk ratio before implanting a lens in a patient with one or more of these conditions: 1. Congenital bilateral cataracts. 2. Recurrent anterior or posterior segment infl ammation of unknown etiology. 3. Patients in whom the intraocular lens may interfere with the ability to observe, diagnose, or treat posterior segment diseases. 4. Surgical diffi culties at the time of cataract surgery which might increase the potential for complications, (e.g., persistent bleeding, signifi cant iris damage, uncontrollable positive pressure, or signifi cant vitreous loss). 5. Patients having only one eye with potentially good vision. 6. Medically uncontrollable glaucoma. 7. Corneal endothelial dystrophy. 8. Proliferative diabetic retinopathy. NOTE: Implantation of these posterior chamber intraocular lenses should not be performed in patients under eighteen years of age. WARNINGS 1. As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: lens dislocation, manifestations of infl ammation, corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, and transient or persistent glaucoma. 2. The safety of intraocular lens implants has not been determined in patients with preexisting ocular conditions (chronic drug miosis, glaucoma, amblyopia, diabetic retinopathy, previous corneal transplant, previous retinal detachment, and/ or iritis, etc.). Physicians considering lens implants in such patients should explore the use of alternative methods of aphakic correction and consider lens implants only if alternatives are deemed unsatisfactory in meeting the needs of the patient. -3-

4 3. The long-term effects of intraocular lens implants have not been determined. Therefore, physicians should continue to monitor patients postoperatively on a regular basis. 4. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea, macular degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from lens implantation when such conditions exist. 5. Patients who experience surgical complications associated with the cataract extraction procedure (posterior capsule rupture, detached Descemet s membrane, anterior chamber bleeding, and vitreous bulge or loss), may experience a higher incidence of inflammatory responses that are generally transient in nature. 6. Patients who experience surgical complications (such as macular edema, iritis, corneal edema, vitritis, retinal detachment, and lens dislocation) may experience poor visual outcome. 7. A secondary iridectomy for pupillary block may be avoided if one or more iridectomies are performed at the time of IOL implantation (Willis, et al., 1985). 8. The physician should be aware that there is a lack of knowledge and data available regarding the long-term effects of intraocular lenses in younger patients. 9. The safety and effectiveness of a posterior chamber lens, if placed in the anterior chamber, has not been established. Implantation of posterior chamber lenses in the anterior chamber has been shown in some cases to be unsafe (Girard, et al., 1983). 10. All convexoplano and mensicus lenses should be implanted with the convex surface anterior. Plano-concave lenses should be implanted with the plano surface anterior. Care must be taken to ensure that lenses with biconvex optics are properly oriented when being implanted. 11. Lens decentration may result in glare or other visual disturbances. When implanting a narrow or small optic lens, it is recommended that capsulorhexis be performed. 12. Lens models MZ60MD and MZ60PD are not intended, nor should they be used, for clear lens exchange. PRECAUTIONS 1. Do not resterilize these intraocular lenses by any method. (See RETURNED GOODS POLICY). 2. Do not store intraocular lenses at temperatures over 45 C (113 F). 3. Use only sterile intraocular irrigating solutions (such as BSS or BSS PLUS solution) to rinse and/or soak lenses. 4. Rubber gloves must not be dusted with powder; polymethylmethacrylate plastic has an affinity for particulate matter. 5. A high level of surgical skill is required for intraocular lens implantation. The surgeon should have observed and/or assisted in numerous implantations and successfully completed one or more courses on intraocular lens implantation before attempting to implant intraocular lenses. CALCULATION OF LENS POWER Preoperative calculation of lens power for these posterior chamber intraocular lenses should be determined by the surgeon s experience, preference, and lens placement. Lens power calculation methods are described in the following references: Hoffer, K.J. The Hoffer Q formula: A comparison of theoretic and regression formulas. J. Cataract Refract. Surg. 19: , Holladay, J.T. et al. A three-part system for refi ning intraocular lens power calculations. J. Cataract Refract. Surg. 14:17-24, Holladay, J.T. et al. Standardizing constants for ultrasonic biometry, keratometry, and IOL power calculations. J. Cataract Refract. Surg. 23: , Retzlaff, J.A., Sanders, D.R., and Kraff, M. Lens Implant Power Calculation, 3rd ed. Slack, Inc., Thorofare, N.J., In the United States, if additional information on lens power calculation is needed, please contact Alcon Laboratories, Inc. Outside the United States, contact local Alcon offices or distributors. DIRECTIONS FOR USE 1. Examine the label on the unopened package for model, power, proper configuration, and expiration date. 2. After opening the cardboard storage container, verify lens case information (e.g., model, power, and serial number) is consistent with information on outer package labeling. 3. To remove the lens, open the pouch and transfer the case to an aseptic environment. Carefully open the case to expose the lens. A smooth, fine forceps is recommended (e.g. Kelman-McPherson) to remove the lens from the lens case by placing one blade under the optic through the access slot. Gently grasp the optic and carefully remove the lens, taking care not to catch or damage the haptics. The lens may be rinsed in sterile intraocular irrigating solution (such as BSS or BSS PLUS solution) prior to implantation. NOTE: Prior to insertion, the lens should be carefully examined to ensure that particles have not adhered during handling. PATIENT REGISTRATION AND REPORTING Each patient must be registered with Alcon Laboratories, Inc. immediately following implantation of one of these lenses. Registration is accomplished by completing the Implant Registration Card that is enclosed in the lens box and mailing it to Alcon Laboratories, Inc. using the postage paid envelope provided. Patient registration is essential for Alcon Laboratories, Inc. long-term patient follow-up program and will assist us in responding to adverse event reports. The Patient Identification Card included in the package is to be completed and given to the patient, together with instructions to keep the card as a permanent record to be shown to any eye care practitioner the patient consults in the future. Adverse events 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 Alcon Laboratories, Inc. -4-

5 This information is being requested from all surgeons in order to document potential long-term effects of intraocular lens implantation. Surgeons should use the following address and telephone number for reporting adverse events involving these lenses: Alcon Laboratories, Inc., Medical Safety (AB 2-6), 6201 South Freeway, Fort Worth, Texas Call Collect: (817) Outside the United States, contact local Alcon offices or distributors regarding reports of adverse events. CLINICAL STUDIES Models CR-1, GR-1, and SM-1 - The clinical results achieved by 504 cohort patients who were followed for one year provides reasonable assurance that these lenses are safe and effective. The clinical study population had a mean age of 67.7 years. There were 61.3% females and 38.7% males. Of the cohort patients, 97.4% were Caucasian, 2.0% were Black, and 0.6% were Other. Models KR2U, SK21U, and S2BU - The clinical results achieved by 508 cohort patients who were followed for one year provides reasonable assurance that lenses with an ultraviolet absorber are safe and effective. The clinical study population had a mean age of 71.0 years. There were 51.4% females and 48.6% males. Of the cohort patients, 98.4% were Caucasian, 1.2% were Black, and 0.4% were Other. VISUAL ACUITY Best case visual acuity attained at months postoperatively by patients receiving lens Models CR-1, GR-1, SM-1 and Models KR2U, SK21U, S2BU are presented in Tables 1 and 1A, respectively. Younger patients achieved the best postoperative visual results, while the poorest visual acuity has been demonstrated in older patients, (e.g., over eighty) with visual acuities less than 20/100 prior to lens implantation. Table 1 Visual Acuity in Best Case Patient Population at 12 to 14 Months for Models CR-1, GR-1, and SM-1 Cohort Study (N = 458) 20/40 or better 20/41-20/100 20/101-20/200 20/201 or worse Total N (%) N (%) N (%) N (%) N Age <60 44 (97.7) 1 (2.3) 0 (0.0) 0 (0.0) (95.3) 7 (3.3) 3 (1.4) 0 (0.0) (95.0) 6 (4.0) 2 (1.0) 0 (0.0) (88.9) 5 (11.1) 0 (0.0) 0 (0.0) 45 Total 434 (94.7) 19 (4.0) 5 (1.3) 0 (0.0) 458 Table 1A Visual Acuity In Best Case Patient Population at 12 to 14 Months for Models KR2U, SK21U, and S2BU Cohort Study (N = 437) 20/40 or better 20/41-20/100 20/101-20/200 20/201 or worse Total N (%) N (%) N (%) N (%) N Age Unknown 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 <60 60 (98.3) 1 (1.7) 0 (0.0) 0 (0.0) (97.1) 4 (2.9) 0 (0.0) 0 (0.0) (98.0) 3 (2.0) 0 (0.0) 0 (0.0) (95.3) 4 (4.7) 0 (0.0) 0 (0.0) 86 Total 425 (97.3) 12 (2.7) 0 (0.0) 0 (0.0) 437 COMPLICATIONS Eleven (11) complications following cataract extraction and/or intraocular lens implantation have been identified by the United States Food and Drug Administration as potentially sight-threatening. The incidence of these complications one year postoperatively is shown in Table

6 Table 2 Cumulative and Persistent Potentially Sight-Threatening Complications for Non-UV-Absorbing Models CR-1, GR-1, SM-1 Cohort Study (N=504) and UV-Absorbing Models KR2U, SK21U, S2BU Cohort Study (N=508) CR-1, GR-1, SM-1 KR2U, SK21U, S2BU Incidence At Incidence At Complication Cumulative Incidence % Cumulative Incidence % Months % Months % Hyphema Macular Edema Pupillary Block Secondary Glaucoma Cyclitic Membrane Vitritis Endophthalmitis Retinal Detachment Corneal Edema Iritis Lens Dislocation Fifty-one (10.1%) cohort patients receiving the non-uv-absorbing lenses (CR-1, GR-1, SM-1) experienced one or more of the above complications. However, these complications occurred early in the postoperative time frame and appear to be associated with the cataract extraction. Ten patients (2.0%) were reported to have these complications months after surgery. Ninetyone (17.9%) cohort patients receiving UV-absorbing lenses (KR2U, SK21U, S2BU) also experienced one or more of these complications. Again however, the complications occurred early in the postoperative time frame and appear to be associated with the cataract extraction. Six patients (1.2%) were reported to have these complications months after surgery. NOTE: Cumulative refers to any complication reported at any time during the clinical study. Persistent refers to any complication reported at months. ADVERSE REACTIONS Adverse reactions were reported at the following rates for the Non-UV-absorbing lens Models CR-1, GR-1, SM-1 (N=504) and UV-absorbing lens Models KR2U, SK21U, S2BU (N=508): Table 3 N= 1012 CR-1, GR-1, SM-1 KR2U, SK21U, S2BU Adverse Reaction % Incidence % Incidence Hypopyon Intraocular Infection Acute Corneal Decompensation Secondary Surgical Intervention Repositioning (0) (0) Replacement (0) (0) Capsular Problem (0) (1) HOW SUPPLIED These posterior chamber intraocular lenses are supplied dry, in a package terminally sterilized with ethylene oxide, and must be opened only under aseptic conditions (See DIRECTIONS FOR USE). EXPIRATION DATE Sterility is guaranteed unless the pouch is damaged or opened. The expiration date is clearly indicated on the outside of the lens package. Any lens held after the expiration date should be returned to Alcon Laboratories, Inc. (See RETURNED GOODS POLICY). RETURNED GOODS POLICY In the United States, returned lenses will only be accepted in exchange for other products, not credit. All returns must be accompanied by an Alcon Laboratories, Inc. Returned Goods Number and be shipped via traceable means. A Returned Goods Number is obtained by contacting Alcon s Customer Service Department. Issuance of this number does not constitute final acceptance of the returned products. For detailed policy guidelines including exchange, please contact your Sales or Customer Service Representative. Outside the United States, contact local Alcon offices or distributors regarding returned goods policy. -6-

7 SYMBOLS USED ON LABELING SYMBOL PMMA ENGLISH Polymethylmethacrylate REFERENCES IOL Intraocular lens Boettner, E.A. and Wolter, J.R. Transmission of PC Posterior chamber the ocular media. Invest. Ophthalmol. PCL Posterior chamber lens 1: , B Biconvex Girard, L.J., et al. Complications of the Simcoe C Convexoplano Flexible Loop Phacoprosthesis in the anterior M Meniscus chamber. Ophthalmic Surg. 14(4): , P Plano-concave Willis, D.A., et al. Pupillary block associated with R Ridged 16(2): , UV Ultraviolet D Diopter Ø B Body diameter (Optic diameter) Ø T Overall diameter (Overall length) Do not reuse Use by (YYYY-MM: year-month) STERILE EO SN Sterilized by ethylene oxide Serial number Attention: See instructions for use Manufacturer EC REP Authorized Representative in the European Community Upper Limit of Temperature Alcon Laboratories, Inc South Freeway Fort Worth, Texas USA EC REP Alcon Laboratories (UK) Ltd. Frimley Business Park Frimley, Camberley Surrey, GU16 7SR, United Kingdom , 2009, 2013 Novartis -7-