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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14603-0450
PMA NumberP010062
Date Received10/26/2001
Decision Date06/07/2004
Product Code NUU 
Docket Number 04M-0260
Notice Date 06/14/2004
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR. THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.50 DIOPTERS. THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
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