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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.
 
DeviceRaindrop Near Vision Inlay
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
REVISION OPTICS, INCORPORATED
25651 atlantic ocean dr ste a1
lake forest, CA 92630
PMA NumberP150034
Date Received09/24/2015
Decision Date06/29/2016
Product Code
LQE[ Registered Establishments with LQE ]
Docket Number 16M-1837
Notice Date 07/08/2016
Advisory Committee Ophthalmic
Clinical Trials NCT01373580
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the Raindrop® Near Vision Inlay. This device is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of (MRSE) +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 
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