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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP960028
Date Received09/03/1996
Decision Date09/05/1997
Product Code MFK 
Docket Number 97M-0499
Notice Date 12/09/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Model SA4ON AMO(R) Array(R) Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL). This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed and who may benefit from useful near vision without reading add and increased spectacle independence across a range of distances where the potential visual effects associated with multifocality are acceptable. The lens is intended to be placed in the capsular bag. The lens is available in powers of +16 to +24 diopters.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S035 S036 S037 S038 S039 
S040 
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