BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 19294201 · Received May 10, 2024

    Report

    Report Number
    3012236936-2024-000137
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Report Date
    May 10, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3, DATE OF EVENT: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D4, CATALOG NUMBER: PARTIAL INFORMATION PROVIDED DUE TO THE UNKNOWN SERIAL NUMBER. SECTION D4, SERIAL NUMBER: UNKNOWN/NO INFORMATION SECTION D4, EXPIRATION DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4, UNIQUE IDENTIFIER (UDI) NUMBER: A PARTIAL UDI WAS PROVIDED AS THE SERIAL NUMBER IS NOT AVAILABLE. SECTION D6A IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B IF EXPLANT; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION H4, DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WILL NOT BE 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. AN ATTEMPT WAS BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, CUSTOMER WAS NOT ABLE TO PROVIDE FURTHER DETAILS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH AT THE 2-3 O¿CLOCK AREA. WHILE PERFORMING A DIFFERENT PROCEDURE THE DOCTOR COMMENTED THAT HE HAD SEEN SCRATCHED IOLS IN A DIFFERENT PCB00 AND ZCB00 PROCEDURE. THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER DETAILS BECAUSE THE ISSUE WAS NOT DOCUMENTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE PCB00 PROCEDURE. REPORT# 3012236936-2024-0001374 CAPTURES THE ZCB00 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905589 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown