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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.
 
DeviceARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
Generic NameLens, intraocular, phakic
ApplicantOPHTEC BV
Schweitzerlaan 15
Groningen 9728
PMA NumberP030028
Date Received07/01/2003
Decision Date09/10/2004
Product Code MTA 
Docket Number 05M-0026
Notice Date 01/21/2005
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS, ALSO KNOWN AS THE VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS TO BE DISTRIBUTED BY ADVANCE MEDICAL OPTICS. THE DEVICE IS INDICATED FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA IN ADULTS WITH MYOPIA RANGING FROM -5 TO -20 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE AND WHOSE EYES HAVE AN ANTERIOR CHAMBER DEPTH GREATER THAN OR EQUAL TO 3.2 MILLIMETERS; AND, 2) PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 6 MONTHS, AS DEMONSTRATED BY SPHERICAL EQUIVALENT CHANGE OF LESS THAN OR EQUAL TO 0.50 DIOPTERS.
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 S008 S009 S012 
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