PMA P880090S020

Device: SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
Applicant: Bausch & Lomb, Inc.
PMA number: P880090
Supplement: S020
Product code: HQL
Decision date: 2004-06-14
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM. STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY. THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH & LOMB, INC., CLEARWATER, FLORIDA.

Current openFDA PMA Record#

Device: SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
Applicant: Bausch & Lomb, Inc.
PMA number: P880090
Supplement: S020
Product code: HQL
Generic name: intraocular lens
Decision date: 2004-06-14
Decision code: APPR
Date received: 2004-03-18
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM. STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY. THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH & LOMB, INC., CLEARWATER, FLORIDA.