Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
• Generic Name: Lens, intraocular, accommodative
• Regulation Number: 886.3600
• Applicant: Bausch & Lomb, Inc.; 50 Technology Dr.; Irvine, CA 92618
• PMA Number: P030002
• Date Received: 01/24/2003
• Decision Date: 11/14/2003
• Product Code: NAA
• Docket Number: 04M-0012
• Notice Date: 01/12/2004
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER IOL. THE DEVICE 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. THE CRYSTALENS IOL PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S040 S039 S025 S033 S029 S031 S010 S011 S001 S002 S017 S015 ; S016 S012 S013 S006 S008 S037 S023 S024 S027 S035 S030 ; S036 S032 S034 S003 S004 S005 S014 S018 S021 S022 S009 S019 ; S020 S038 S028