Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: BAUSCH & LOMB; 50 Technology Drive; Irvine, CA 92618
• PMA Number: P910061
• Date Received: 10/08/1991
• Decision Date: 09/02/1994
• Product Code: HQL
• Docket Number: 94M-0339
• Notice Date: 10/14/1994
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls
• Supplements: S020 S022 S003 S004 S011 S012 S001 S009 S010 S015 S016 ; S017 S005 S006 S007 S008 S013 S014 S019 S018 S023 S025 S026 ; S027