PMA P960028S010

Device: ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S010
Product code: MFK
Decision date: 2003-08-25
Generic name: Lens, multifocal intraocular
Approval order statement: APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."

Current openFDA PMA Record#

Device: ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S010
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2003-08-25
Decision code: APPR
Date received: 2003-08-06
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."