PMA P910061S013

Device: LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS
Applicant: Bausch & Lomb
PMA number: P910061
Supplement: S013
Product code: HQL
Decision date: 2006-07-20
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR LABELING CHANGES FOR THE ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS AND IS INDICATED TO BE USED FOR PRIMARY IMPLANTATION FOR THE CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION METHODS. THE LENS IS INTENDED FOR PLACEMENT IN THE CILIARY SULCUS OR CAPSULAR BAG.

Current openFDA PMA Record#

Device: LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS
Applicant: Bausch & Lomb
PMA number: P910061
Supplement: S013
Product code: HQL
Generic name: intraocular lens
Decision date: 2006-07-20
Decision code: APPR
Date received: 2006-03-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR LABELING CHANGES FOR THE ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS AND IS INDICATED TO BE USED FOR PRIMARY IMPLANTATION FOR THE CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION METHODS. THE LENS IS INTENDED FOR PLACEMENT IN THE CILIARY SULCUS OR CAPSULAR BAG.