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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP910056
Supplement NumberS010
Date Received09/12/2011
Decision Date05/30/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Clinical Trials NCT01230060
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a material change and design modifications (3-piece to 1-piece design and aspheric surface) to the approved bausch & lomb silicone lens c31ub. The device, as modified, will be marketed under the trade name envista one-piece hydrophobic acrylic intraocular lens, model mx60 and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous crystalline lens has been removed.