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: S022 S018 S009 S010 S015 S007 S008 S003 S004 S005 S006 ; S001 S020 S013 S014 S011 S012 S016 S019 S017 S023 S026 S025 ; S027