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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameXACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB INCORPORATED
PMA NumberP080021
Date Received08/07/2008
Decision Date02/02/2009
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 09M-0049
Notice Date 02/06/2009
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the xact foldable hydrophobic acrylic ultraviolet light-absorbing posterior chamber intraocular lens (iol). Model x-60 and model x-70. This device is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.
Approval Order Approval Order
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