PMA P840060S028

Device: ACRYSOF UV-ABSORBING SINGLE-PIECE PC IOL
Applicant: Alcon Laboratories
PMA number: P840060
Supplement: S028
Product code: HQL
Decision date: 2004-04-29
Generic name: intraocular lens
Approval order statement: APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.

Current openFDA PMA Record#

Device: ACRYSOF UV-ABSORBING SINGLE-PIECE PC IOL
Applicant: Alcon Laboratories
PMA number: P840060
Supplement: S028
Product code: HQL
Generic name: intraocular lens
Decision date: 2004-04-29
Decision code: APPR
Date received: 2004-04-16
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.