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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameKAMRA INLAY
Classification Nameimplant, corneal, refractive
ApplicantACUFOCUS
PMA NumberP120023
Date Received12/12/2012
Decision Date04/17/2015
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Clinical Trials NCT00819299
NCT00850031
NCT01352442
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the kamra inlay. The kamra inlay is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0. 50 d to -0. 75 d with less than or equal to 0. 75 d of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1. 00 d to +2. 50 d of reading add.
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