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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.
 
DeviceVisian Toric ICL (IMPLANTABLE COLLAMER LENS)
Classification Namephakic toric intraocular lens
Generic Namephakic toric intraocular lens
Regulation Number886.3600
Applicant
STAAR Surgical Company
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Supplement NumberS001
Date Received04/28/2006
Decision Date09/13/2018
Product Code
QCB[ Registered Establishments with QCB ]
Docket Number 18M-3503
Notice Date 09/20/2018
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Visian® Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age:1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D;2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.0D;3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5D for both spherical equivalent and cylinder for 1 year prior to implantation); and4) The Visian® TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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