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 RESTOR INTRAOCULAR LENSES
• Generic Name: Lens, multifocal intraocular
• Regulation Number: 886.3600
• Applicant: Alcon Research, Ltd.; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P040020
• Supplement Number: S035
• Date Received: 08/29/2011
• Decision Date: 09/26/2011
• Product Code: MFK
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
IMPLEMENT TIGHTER TEMPERATURE AND RELATIVE HUMIDITY CONTROLS IN THE FORMULATION PROCESS OF THE PRODUCTS.