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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RVO 2.0, INC. RAINDROP INLAY; IMPLANT, CORNEAL, REFRACTIVE

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RVO 2.0, INC. RAINDROP INLAY; IMPLANT, CORNEAL, REFRACTIVE Back to Search Results
Model Number RD1-1
Device Problem Nonstandard Device (1420)
Patient Problems Headache (1880); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Twitching (2172)
Event Date 01/05/2018
Event Type  Injury  
Event Description
I had the rain drop implanted in my left eye on (b)(6) 2018.I had a horrible experience.A few hours after surgery, i had severe (crying) pain.I couldn't read my computer for work.The starburst and glares were terrible.I was afraid i would get into an accident while driving, due to object being so distorted.I found myself getting off the road because i couldn't be sure which lane cars were in.It was too hazardous for me to drive at night.I could read the eye chart, but the black letters were blurry, light gray in color and distorted.I was told that my vision had greatly improved, impossible.My raindrop was removed a year later.I'm experiencing sharp pain in my eye, headaches, twitching of the eye and constant dry eye.I'm back to using eye glasses.I'm concerned this nightmare is not over.Ridiculous.Class 1 recall of all devices.
 
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Brand Name
RAINDROP INLAY
Type of Device
IMPLANT, CORNEAL, REFRACTIVE
Manufacturer (Section D)
RVO 2.0, INC.
MDR Report Key8470635
MDR Text Key140583520
Report NumberMW5085424
Device Sequence Number1
Product Code LQE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberRD1-1
Device Catalogue NumberRD1-1
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient Weight68
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