PRODUCT INFORMATION Alcon Laboratories, Inc. KELMAN® MULTIFLEX™1 III STERILE UV-Absorbing PMMA Single-Piece Anterior Chamber Lenses

PRODUCT INFORMATION Alcon Laboratories, Inc. KELMAN® MULTIFLEX™1 III STERILE UV-Absorbing PMMA Single-Piece Anterior 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 Haptic Vault Height (mm) None None None None None None DESCRIPTION Alcon UV-absorbing PMMA single-piece anterior chamber lenses are designed to be positioned anterior to the iris where it should replace the optical function of the natural crystalline lens. However, accommodation will not be replaced. The physical...

MECHANICAL CHARACTERISTICS 1. The force required to compress the diameter of the anterior chamber IOL 0.5 mm: 0.89 gm for MTA2U (12.0 mm) - 1.13 gm for MTA7U (14.5 mm). 2. The force required to compress the diameter of the lens 0.5 mm less than the original diameter after it has been compressed 0.5 mm for 24 hours at 37°C in saline: 0.98 gm for MTA2U (12.0 mm) - 0.78 gm for MTA7U (14.5 mm). 3. The vault observed after compressing the diameter of the lens 1.5 mm: 0.26 mm for MTA2U (12.0 mm) - 0.29 mm for MTA7U (14.5 mm). The force required to compress the lens 1.5 mm: 2.91 gm for MTA2U (12.0 mm)...

CAUTION When considering the implantation of IOLs of powers at extreme ends of the available power range, special consideration should be given to the dimensions of these lenses in relation to the anatomical clearances in the patient’s eyes. The potential impact of factors such as optic central thickness, optic edge thickness and overall lens size on these patients’ long-term clinical outcome must be carefully weighed against the potential benet associated with the implantation of an IOL, and the patients’ clinical progress should be carefully monitored. Under certain circumstances, there may...

CALCULATION OF LENS POWER Preoperative calculation of lens power for these anterior chamber 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. 19:700712, 1993. Holladay, J.T. et al. A three-part system for rening intraocular lens power calculations. J. Cataract Refract. Surg. 14:1724, 1988. Holladay, J.T. et al. Standardizing constants for ultrasonic biometry, keratometry,...

ONE YEAR DATA Table 2 One Year Best Case Visual Acuity by Age Decade & Type of Surgery (n= 3792) Age <60 A = Primary ICCE With Operative Problems B = Primary ICCE Without Operative Problems C = Primary ECCE D = Secondary E = Total When added, A through D do not add up to E as surgical intent (Primary/Secondary) and/or extraction type (ICCE/ECCE) was not reported for 4 subjects. 2

Sight-Threatening Complications at One Year GroupAjn = 80), Group B (n = 247), Group C (n = 60), Group D (n = 173), Group E (n = 5643) A= Pnmaiy ICCE With Operatwe Problems B = Pnmaiy ICCE Without Operative Problems C = Pnmaiy ECCE 3 When added, A through D do not total 564 as surgical intent (Primary/Secondary) and/or extraction type (ICCECCCE) was not

Table 4 Adverse Reactions at One Year Group A (n = 137), Group B (n = 337), Group C (n = 109), Group D (n = 311), Group E (n =9004) Adverse Reaction Hypopyon Group n % A 0 0.0 B 1 0.3 C 0 0.0 D 0 0.0 E4 1 0.1 Intraocular Infection A 0 0.0 B 1 0.3 C 2 1.8 D 1 0.3 4 E 4 0.4 Acute Corneal Decompensation A 0 0.0 B 1 0.3 C 0 0.0 D 1 0.3 2 0.2 E4 Surgical Reinterventation A 1 0.7 B 3 0.9 C 12 11.0 D 2 0.6 E4 18 2.0 A = Primary ICCE With Operative Problems B = Primary ICCE Without Operative Problems C = Primary ECCE D = Secondary E = Total 4 When added, A through D do not total 900 as surgical intent...

Sight-Threatening Complications at Three Years Group A (n = 13), Group B (n = 259), Group C (n = 59), Group D (n = 169), Group E (n =500) A = Pnmaiy ICCE With OperatweProblems B = Pnmaiy ICCE WithoutOperatweProblems C = Pnmaiy ECCE

Table 7 Adverse Reactions at Three Years Group A (n = 137), Group B (n = 337), Group C (n = 109), Group D (n = 311), Group E (n = 9005) Adverse Reaction Hypopyon Intraocular Infection Acute Corneal Decompensation Surgical Reinterventation A = Primary ICCE With Operative Problems B = Primary ICCE Without Operative Problems C = Primary ECCE D = Secondary E = Total 5 When added, A through D do not total 900 as surgical intent (Primary/Secondary) and/or extraction type (ICCE/ECCE) was not reported for 6 subjects. HOW SUPPLIED These anterior chamber intraocular lenses are supplied dry, in a package...

REFERENCES Boettner, E.A. and Wolter, J.R. Transmission of the ocular media. Invest. Ophthalmol. 1:776-783, 1962. Girard, L.J., et al. Complications of the Simcoe Flexible Loop Phacoprosthesis in the anterior chamber. Ophthalmic Surg. 14(4):332-335, 1983. Willis, D.A., et al. Pupillary block associated with posterior chamber lenses. Ophthalmic Surg. 16(2):108-109, 1985. SYMBOLS USED ON LABELING SYMBOL Intraocular lens Anterior chamber Anterior chamber lens Body diameter (Optic diameter) Overall diameter (Overall length) Do not reuse Use by (YYYY-MM: year-month) Sterilized by ethylene oxide Serial...