BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 20626326 · Received November 7, 2024

    Report

    Report Number
    3012236936-2024-000291
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Report Date
    November 15, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531789
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3B, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: UNKNOWN/NOT PROVIDED. BEST ESTIMATE IS BETWEEN DEVICE MANUFACTURE DATE 23-APR-2024 AND DATE RECEIVED BY MANUFACTURER 15-OCT-2024. SECTION D6A - IMPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. SECTION E1 - FIRST/GIVEN NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - LAST NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND CORRECTED DATA: PER FURTHER INFORMATION RECEIVED, THE EVENT OCCURRED ON (B)(6) 2024 AND THE DEFECT WAS A SCRATCH ON THE OPTIC. ACCOUNT INDICATED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. UPON FURTHER REVIEW OF THE NEW INFORMATION RECEIVED IT WAS DETERMINED THAT THE REPORTED INCIDENT IS NOT LINKED TO THE DEVICE AS THERE WAS NO PATIENT CONTACT. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER MFR REPORT NUMBER 3012236936-2024-0002918. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405064 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown