BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 16212033 · Received January 19, 2023

    Report

    Report Number
    3012236936-2023-00097
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Report Date
    January 25, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION UNKNOWN/ NOT PROVIDED. PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. DATE OF EVENT: UNKNOWN, NOT PROVIDED. MODEL #: UNKNOWN/ NOT PROVIDED. SERIAL#: UNKNOWN/ NOT PROVIDED. CATALOGUE#: UNKNOWN/ NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. TELEPHONE NUMBER:(B)(6). THE DEVICES WERE NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THE DEVICES WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: REPORT WAS SUBMITTED WITHOUT PROCODE. PROCODE IS HQL.

    Description of Event or Problem · 0

    THE CUSTOMER ASKED TO PICK-UP BROKEN LENSES THAT THEY HAD ON SITE. IT IS UNKNOWN HOW MANY LENSES THEY ARE REPORTING AND THEIR SERIAL NUMBERS ARE NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378057 UNKNOWN UNKNOWN HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown