PMA P830071S009

Device: OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392
Applicant: Alcon Laboratories
PMA number: P830071
Supplement: S009
Product code: LPN
Decision date: 1997-03-19
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR A MODIFICATION IN THE PACKAGE INSERT TO INCLUDE ADDITION OF THE FOLLOWING STATEMENT IN THE DIRECTIONS SECTIONS: "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS. IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR."

Current openFDA PMA Record

Device: OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392
Applicant: Alcon Laboratories
PMA number: P830071
Supplement: S009
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-03-19
Decision code: APPR
Date received: 1997-03-04
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A MODIFICATION IN THE PACKAGE INSERT TO INCLUDE ADDITION OF THE FOLLOWING STATEMENT IN THE DIRECTIONS SECTIONS: "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS. IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR."