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: FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Alcon Laboratories, Inc.; 6201 South Freeway; Fort Worth, TX 76134-2099
• PMA Number: P830037
• Supplement Number: S042
• Date Received: 04/07/1999
• Decision Date: 05/07/1999
• Withdrawal Date: 02/27/2019
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for the following: 1) minor modification of the polymer formulation to include changes in the ratio of ingredients; 2) configuration change to include a bifocal design for the device; 3) modifications to the labeling to include the presbyopic indication and add the sentence "FreshLook(R) Lenses with UV-absorbing monomer help protect against the transmission of harmful UV radiation tot he cornea and into the eye"; 4) modification of the Note and Warning; 5) combining the package inserts for the bifocal, spherical and toric configurations; and 6) minor editorial changes to the spherical and toric indications.