PMA P030002S004

Device: CRYSTALENS SE, MODEL AT-45 SE
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S004
Product code: NAA
Decision date: 2005-09-08
Generic name: Lens, intraocular, accommodative
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PHYSICIAN'S LABELING: CHANGE IN THE MODEL NUMBER AND TRADE NAME; CHANGE IN DIRECTIONS FOR USE TO FACILITATE PROPER INSERTION AND ORIENTATION OF THE LENS; AND, CHANGE IN THE EXISTING RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS SE (MODEL AT-45 SE) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA. THE CRYSTALENS SE (MODEL AT-45 SE) PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION WHICH ALLOWS FOR NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.

Current openFDA PMA Record#

Device: CRYSTALENS SE, MODEL AT-45 SE
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S004
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2005-09-08
Decision code: APPR
Date received: 2005-07-05
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PHYSICIAN'S LABELING: CHANGE IN THE MODEL NUMBER AND TRADE NAME; CHANGE IN DIRECTIONS FOR USE TO FACILITATE PROPER INSERTION AND ORIENTATION OF THE LENS; AND, CHANGE IN THE EXISTING RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS SE (MODEL AT-45 SE) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA. THE CRYSTALENS SE (MODEL AT-45 SE) PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION WHICH ALLOWS FOR NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.