PMA P960028S024

Device: ARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S024
Product code: MFK
Decision date: 2007-10-24
Generic name: Lens, multifocal intraocular
Approval order statement: INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.

Current openFDA PMA Record#

Device: ARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S024
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2007-10-24
Decision code: OK30
Date received: 2007-09-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.