PMA P910061S016

Device: SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Bausch & Lomb
PMA number: P910061
Supplement: S016
Product code: HQL
Decision date: 2008-05-02
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.

Current openFDA PMA Record#

Device: SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Bausch & Lomb
PMA number: P910061
Supplement: S016
Product code: HQL
Generic name: intraocular lens
Decision date: 2008-05-02
Decision code: OK30
Date received: 2008-04-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.