SILICONE INTRAOCULAR LENSES

FDA premarket approval P910061/S009 · decided 2003-08-13

Approval details

PMA number

P910061

Supplement

S009

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SILICONE INTRAOCULAR LENSES

Generic name

intraocular lens

Applicant

Bausch & Lomb

Date received

2003-06-11

Decision date

2003-08-13

Days to decision

63 days

Decision code

APPR

Product code

HQL

Advisory committee

Ophthalmic

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.

510(k) clearances by this applicant