BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 21678915 · Received March 24, 2025

    Report

    Report Number
    MW5168068
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    September 25, 2024
    Report Date
    March 18, 2025
    Manufacturer
    UNK
    Product Code
    LQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED RAINDROP CORNEAL IMPLANT DURING LASIK SURGERY IN (B)(6) 2017. PRIOR TO CATARACT SURGERY, MY EYE SURGEON THOUGHT IT BEST TO REMOVE THE RAINDROP BECAUSE OF SCARRING. (B)(6) 2024, THE INLAY WAS REMOVED. HAZE FROM SCARRING REMAINS BAD AFTER 6 MONTHS. MFR: REVISION OPTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432692 RAINDROP NEAR VISION INLAY IMPLANT, CORNEAL, REFRACTIVE LQE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female BIOTIN.| FISH OIL.| LUTEIN.| PROBIOTICS.| VITAMIN K & D3.