BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUNDUS LASER LENS

    MDR report key: 12835706 · Received November 17, 2021

    Report

    Report Number
    MW5105451
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    June 14, 2021
    Report Date
    November 15, 2021
    Manufacturer
    UNK
    Product Code
    HJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT LASER RETINOPEXY OF RETINAL TEAR ON (B)(6) 2021. AN OPHTHALMIC FUNDUS LENS WAS USED. THE CLEAR FOOTPLATE OF THE LENS BECAME DISCONNECTED AND REMAINED ON THE SURFACE OF HER EYE, CAUSING IRRITATION. SHE RETURNED ON (B)(6) 2021 COMPLAINING OF BLURRY VISION. THE CLEAR LENS WAS REMOVED AND HER SYMPTOMS RESOLVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724574 FUNDUS LASER LENS LENS, FUNDUS, HRUBY, DIAGNOSTIC HJI UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention