BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 14592838 · Received June 2, 2022

    Report

    Report Number
    MW5110072
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    February 11, 2022
    Report Date
    May 31, 2022
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RAINDROP CORNEAL IMPLANT WAS IMPLANTED IN 2016 WHEN I WAS HAVING TROUBLE READING SMALL PRINT. AFTER INITIAL IMPROVEMENT MY VISION DETERIORATED PAST THE ORIGINAL STATE. I WENT TO HAVE THE IMPLANT REMOVED ON (B)(6) 2021. I WAS TOLD THAT IT WOULD TAKE SEVERAL MONTHS FOR VISION TO RETURN TO WHAT WOULD BE NORMAL. I NOW HAVE CLOUDY VISION IN THE LEFT EYE AND CANNOT USE IT TO READ OR MUCH OF ANYTHING ELSE. I AM UNABLE TO FOCUS MY EYES AND GET CONTINUOUS HEADACHES, EYE ACHES, DRY EYE, AND NAUSEA, AS WELL AS ISSUES WITH DEPTH PERCEPTION. RVO 2.0 INC., (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161542 RAINDROP NEAR VISION INLAY IMPLANT, CORNEAL, REFRACTIVE LQE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other| S 2 HEART STENTS | ASPIRIN | ATORVASTATIN 80MG TAB | CLONAZEPAM 1MG TAB AS NEEDED | CLOPIDOGREL 75MG TAB | FENOFIBRATE 160MG TAB| FISH OIL | FLOMAX 0.4MG CAP | FLUOXETINE 40MG CAP| LISINOPRIL 2.5MG TAB | MELATONIN | OXCARBAZEPINE 600MG TAB | QUETIAPINE FUMARAT 50MG TAB | VITAMIN D2 (ERGO)50,000IU CAP