PMA P890023S004

Device: OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S004
Product code: LPM
Decision date: 1996-08-28
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR THE FOLLOWING: 1)MODIFYING THE MANUFACTURING PROCESS FOR THE OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR LENSES FROM A LOCATOR TINT DIPPING PROCESS AT THE END OF THE MANUFACTURING PROCEDURE TO THE ADDITION OF AN IN-MONOMER TINT INCORPORATING VAT BLUE 6 DYE DURING THE POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2)USING BLISTER PACKAGINAS ALTERNATE PACKAGING MATERIAL; AND 3)ADDING THE FOLLOWING ALTERNATE MANUFACTUIRING SITE FOR LENSES MANUFACTURED BY THE PROCESS DESCRIBED IN ITEM 1: OCULAR SCIENCES/AMERICAN HYDRON, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE S053 4 ND, ENGLAND

Current openFDA PMA Record#

Device: OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S004
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1996-08-28
Decision code: APPR
Date received: 1995-10-02
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE FOLLOWING: 1)MODIFYING THE MANUFACTURING PROCESS FOR THE OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR LENSES FROM A LOCATOR TINT DIPPING PROCESS AT THE END OF THE MANUFACTURING PROCEDURE TO THE ADDITION OF AN IN-MONOMER TINT INCORPORATING VAT BLUE 6 DYE DURING THE POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2)USING BLISTER PACKAGINAS ALTERNATE PACKAGING MATERIAL; AND 3)ADDING THE FOLLOWING ALTERNATE MANUFACTUIRING SITE FOR LENSES MANUFACTURED BY THE PROCESS DESCRIBED IN ITEM 1: OCULAR SCIENCES/AMERICAN HYDRON, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE S053 4 ND, ENGLAND