OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION

FDA premarket approval P830034/S033 · decided 1997-03-19

Approval details

PMA number

P830034

Supplement

S033

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION

Generic name

Accessories, soft lens products

Applicant

Alcon Laboratories

Date received

1997-03-04

Decision date

1997-03-19

Days to decision

15 days

Decision code

APPR

Product code

LPN

Advisory committee

Ophthalmic

Expedited review

No

Location

Van Nuys, CA

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."

510(k) clearances by this applicant