BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMO TAC VITRECTOMY HANDPIECE

    MDR report key: 15955351 · Received December 9, 2022

    Report

    Report Number
    3012236936-2022-02909
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 28, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HKP
    UDI-DI
    0(01)(21)11442
    PMA / PMN Number
    K760684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE. TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6: MEDICAL DEVICE PROBLEM CODE FROM 1318 - LABELLING, INSTRUCTIONS FOR USE OR TRAINING PROBLEM TO 3191 - UNSPECIFIED/OTHER W/O PATIENT INVOLVEMENT. ADDITIONAL RESPONSE: ON FURTHER ASSESSMENT, THE PRODUCT HAD A COUNTERFEIT LABEL AND THERE WAS NO ALLEGATION AGAINST THE JNJ LABEL. AS SUCH, IT HAS BEEN ASSESSED AS NOT REPORTABLE IN THE CURRENT STATE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACCOUNT CHINESE PEOPLE 'S LIBERATION ARMY 96601 HOSPITAL PURCHASED A PHACO HANDPIECE OF UNKNOWN ORIGIN, WHICH MAY HAVE AN UNKNOWN IMPACT ON SURGICAL SAFETY AND PHACO MACHINES. IT WAS ALSO NOTED THAT THE LABELING ON THE HANDPIECE PACKING BOX WAS INCONSISTENT WITH THAT OF THE HANDPIECE REGULAR CHANNEL OF J&J SURGICAL VISION, SO THE COMPATIBILITY OF THE HANDPIECE WITH PHACO SOVEREIGN COMPANY MACHINE WAS UNKNOWN AND THIS LED TO A QUESTION OF THE SURGICAL SAFETY AND NORMAL OPERATION OF THE INSTRUMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229698 AMO TAC VITRECTOMY HANDPIECE INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED HKP AMO PUERTO RICO MFG. INC. OM0201011D 0(01)(21)11442

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown