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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCEEON MODEL 912 FOLDABLE INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAdvanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana, CA 92705
PMA NumberP940007
Supplement NumberS005
Date Received07/01/1999
Decision Date07/30/1999
Withdrawal Date01/22/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the Warning Section of the lens package insert. Specifically: "When implanting a lens with a smaller optic (less than or equal to 5.5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended."
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