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: HIGH CYLINDER POWER ACRYSOF IQ TORIC IOLS
• 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: S082
• Date Received: 07/20/2015
• Decision Date: 09/18/2015
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.