Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ACRYSOF INTRAOCULAR LENSES
• Classification Name: intraocular lens
• Generic Name: intraocular lenses (iol)21 cfr 886.3600/class iii
• Regulation Number: 886.3600
• Applicant: ALCON RESEARCH, LTD.
• PMA Number: P930014
• Supplement Number: S054
• Date Received: 08/29/2011
• Decision Date: 09/26/2011
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Implement tighter temperature and relative humidity controls in the formulation process of the products.