BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER

    MDR report key: 13783608 · Received March 15, 2022

    Report

    Report Number
    MW5108192
    Event Type
    Injury
    Date Received
    March 15, 2022
    Report Date
    March 12, 2022
    Manufacturer
    UNK
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FOLLOW ON SURGERY 3X CXL; LASIK SURGERY IN (B)(6) 2006. DIAGNOSED WITH CORNEAL ECTASIA IN 2011. PRIOR SCANS SHOWED A HIGH RISK AND NO WARNING OF THIS RISK. FOLLOW ON SURGERY OF COLLAGEN CROSS LINKING (CXL) TO BOTH EYES, RIGHT EYE IN 2012 AND 2022, LEFT EYE IN 2015. CONTINUOUS USE OF HYLOFORTE, FML AND OPATANOL FOR ONGOING SYMPTOMS SINCE 2011. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42557 LASER EXCIMER LASER SYSTEM LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R CETIRIZINE HYDROCHLORIDE | FML OPATANOL | HYLOFORTE| SYMBICORT | TURBO INHALER