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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVISIAN ICL (IMPLANTABLE COLLAMER LENS)
Classification Namelens, intraocular, phakic
Generic Namephakic intraocular lens for myopic correction
ApplicantSTAAR SURGICAL CO.
PMA NumberP030016
Date Received05/08/2003
Decision Date12/22/2005
Product Code
MTA[ Registered Establishments with MTA ]
Docket Number 06M-0340
Notice Date 08/25/2006
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S016 S017 S018 S019 S020 S023 
S025 S026 
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