PMA P030002S021

Device: CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S021
Product code: NAA
Decision date: 2009-10-23
Generic name: Lens, intraocular, accommodative
Approval order statement: APPROVAL FOR THE ADDITION OF AN ASPHERIC SURFACE TO THE APPROVED PARENT CRYSTALENS IOL MODEL AT-45. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS MODELS AT50AO AND AT52AO AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND IS INTENDED TO PROVIDE NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.

Current openFDA PMA Record#

Device: CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S021
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2009-10-23
Decision code: APPR
Date received: 2009-08-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF AN ASPHERIC SURFACE TO THE APPROVED PARENT CRYSTALENS IOL MODEL AT-45. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS MODELS AT50AO AND AT52AO AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND IS INTENDED TO PROVIDE NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.