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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTICS MEDICAL / RVO 2.0, INC RAINDROP; IMPLANT, CORNEAL, REFRACTIVE
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OPTICS MEDICAL / RVO 2.0, INC RAINDROP; IMPLANT, CORNEAL, REFRACTIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Increased Sensitivity (2065); Visual Impairment (2138); Visual Disturbances (2140)
Event Date 04/03/2020
Event Type  Injury  
Event Description
I had a raindrop inlay implanted into my left eye in 2018.There was a very drastic side effect that i was not expecting.My distance vision was exceptionally bad and could not be corrected with glasses.I was told it would improve and was probably caused by dry eye.I underwent a recommended procedure to correct the dry eye along with using recommended eye drops numerous time each day.Near distance vision did improve, but any object more than a few feet away was out of focus and was not correctable with glasses.My vision has steadily gotten worse.I also have started experiencing bad headaches, a sporadic diagonal prism effect, and bad light sensitivity, or difficulties driving at night due to oncoming headlights.I also have sporadic (numerous times a week) issues trying to focus on a computer screen because of the glare.I believe i was badly mislead as to the expected outcome.I was not expecting my distance vision to be destroyed or have recurring headaches.Fda safety report id # (b)(4).
 
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Brand Name
RAINDROP
Type of Device
IMPLANT, CORNEAL, REFRACTIVE
Manufacturer (Section D)
OPTICS MEDICAL / RVO 2.0, INC
MDR Report Key11392269
MDR Text Key234426597
Report NumberMW5099692
Device Sequence Number1
Product Code LQE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
Patient Weight75
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