BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON IOL

    MDR report key: 20256206 · Received September 19, 2024

    Report

    Report Number
    20256206
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 7, 2024
    Manufacturer
    ALCON LABORATORIES INC
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    LENS WAS STUCK IN CARTRIDGE. REPORTED & RETURNED RGA# [REDACTED], FEDEX TRK# [REDACTED]. MANUFACTURER RESPONSE FOR IOL, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591572 ALCON IOL INTRAOCULAR LENS HQL ALCON LABORATORIES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female