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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACRYSOF IQ RESTOR INTRAOCULAR LENSES
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS030
Date Received02/10/2011
Decision Date03/09/2011
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a software modification to enhance and improve intraocular lens production.
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