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: EZE-FIT(TM)
• Classification Name: intraocular lens
• Generic Name: contact lenses
• Regulation Number: 886.3600
• Applicant: STORZ OPHTHALMICS, INC.
• PMA Number: P840039
• Supplement Number: S048
• Date Received: 10/10/1995
• Decision Date: 07/18/1996
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the trade name eze-fit for your one-piece polymethylmethacrylate intraocular lenses.