BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP INLAY

    MDR report key: 13500072 · Received February 8, 2022

    Report

    Report Number
    MW5107324
    Event Type
    Injury
    Date Received
    February 8, 2022
    Report Date
    February 6, 2022
    Manufacturer
    REVISION OPTICS / RVO 2.0, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RAINDROP INLAY IN-PLANTED ON OR ABOUT (B)(6) 2018; 6 MONTHS LATER WAS NO LONGER AFFECTIVE. REMOVED (B)(6) 2022. NOW I HAVE PERMANENT BLURRED VISION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757350 RAINDROP INLAY IMPLANT, CORNEAL, REFRACTIVE LQE REVISION OPTICS / RVO 2.0, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Disability| O ATORVASTATIN| FISH OIL| GLIPIZIDE| JANUMET| LATANOPROST