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: TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
• Generic Name: Lens, multifocal intraocular
• Regulation Number: 886.3600
• Applicant: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr. Suite 200; Irvine, CA 92618
• PMA Number: P080010
• Date Received: 04/02/2008
• Decision Date: 01/16/2009
• Product Code: MFK
• Docket Number: 09M-0034
• Notice Date: 01/27/2009
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), MODELS ZM900 AND ZMA00.THE DEVICES ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 ; S013 S014 S015 S016 S017 S018 S020 S021 S022 S024 S025 S026 ; S027 S028 S029 S030