PMA P960028S019

Device: REZOOM MULTIFOCAL IOLS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S019
Product code: MFK
Decision date: 2007-04-26
Generic name: Lens, multifocal intraocular
Approval order statement: REDUCE OPERATOR HANDLING OF LENSES BY ELIMINATING THE 100% VISUAL INSPECTION PROCESSING STEP CONDUCTED AT POST-TUMBLING FOR ALL OF THE SOFT ACRYLIC IOLS.

Current openFDA PMA Record#

Device: REZOOM MULTIFOCAL IOLS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S019
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2007-04-26
Decision code: OK30
Date received: 2007-03-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REDUCE OPERATOR HANDLING OF LENSES BY ELIMINATING THE 100% VISUAL INSPECTION PROCESSING STEP CONDUCTED AT POST-TUMBLING FOR ALL OF THE SOFT ACRYLIC IOLS.