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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.
 
DeviceFOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP000030
Supplement NumberS001
Date Received02/16/2016
Decision Date03/14/2016
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Revision of internal procedures to harmonize the nomenclature for identifying the tooling used to manufacture approved contact lenses at the Johor and Atlanta manufacturing facilities; and development and implementation of a plan to validate and verify the fabrication of Lotrafilcon B Toric optical tools at the Johor manufacturing facility.
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