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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.
 
DeviceVISIAN ICL (IMPLANTABLE COLLAMER LENS)
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP030016
Date Received05/08/2003
Decision Date12/22/2005
Product Code MTA 
Docket Number 06M-0340
Notice Date 08/25/2006
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODELS MICL12.1, MICL12.6, MICL13.2 AND MICL13.7. THE DEVICE IS INDICATED FOR ADULTS 21-45 YEARS OF AGE: 1) TO CORRECT MYOPIA RANGING FROM -3.0 DIOPTERS TO <=-15.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) TO REDUCE MYOPIA RANGING FROM GREATER THAN -15.0 DIOPTERS TO -20.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; AND 3) WITH AN ANTERIOR CHAMBER DEPTH (ACD) 3.00 MM OR GREATER, AND A STABLE REFRACTIVE HISTORY WITHIN 0.5 DIOPTER FOR 1 YEAR PRIOR TO IMPLANTATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S014 S015 S016 S017 S018 S019 S020 S022 S023 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S046 
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