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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCT LUCIA 202 IOL and CT LUCIA 602 IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production, LLC
1040 S. Vintage Ave., Bldg. A
Ontario, CA 91761
PMA NumberP100016
Supplement NumberS004
Date Received05/22/2017
Decision Date08/09/2017
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for change in product name from Aaris® EC-3 and Aaris® EC-3 PAL to CT LUCIA 202 and CT LUCIA 602 respectively; minor product labeling changes to include the unit container box, adhesive label, Instructions for Use and patient card; and a new contact/manufacturing address.
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