Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Alcon Laboratories, Inc.; 6201 S. Fwy. Dr.; Fort Worth, TX 76134
• PMA Number: P930014
• Supplement Number: S096
• Date Received: 10/26/2016
• Decision Date: 01/13/2017
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for modifying the physician directions for use to include instructions for removing the IOL from the injector.