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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
Generic Nameimplant, corneal, refractive
ApplicantRVO 2.0, Inc. (d.b.a. Optics Medical)
65 enterprise suite 455
aliso viejo, CA 92656
PMA NumberP150034
Date Received09/24/2015
Decision Date06/29/2016
Product Code LQE 
Docket Number 16M-1837
Notice Date 07/08/2016
Advisory Committee Ophthalmic
Clinical TrialsNCT01373580
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003  S001 S002 S009 S004 S005 S006 S007 S008 
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