BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21379077 · Received February 13, 2025

    Report

    Report Number
    3012236936-2025-000043
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Report Date
    August 11, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A3B, A4 AND A5: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. SECTION H3: 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 AND REPORTABILITY DOWNGRADED MDR: UPON FURTHER REVIEW, IT WAS NOTICED THAT THIS REPORT IS DUPLICATE OF MFR REPORT NUMBER 3012236936 - 2025-0000343. PLEASE REFER TO MFR REPORT NUMBER 3012236936 - 2025-0000343 FOR ANY FURTHER INFORMATION ON THIS SERIAL NUMBER INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DEBRIS FOUND ON THE BACK OF THE PRELOADED INTRAOCULAR LENS (IOL). NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637443 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown