BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20928958 · Received December 13, 2024

    Report

    Report Number
    3012236936-2024-000333
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 15, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731721
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS PROVIDED AND REPORTED THE EXPLANT WAS PERFORMED ON THE (B)(6) 2024. THERE WAS NO UNPLANNED SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 PRELOADED DEVICE 20.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE LENS IS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE REPLACEMENT LENS (SAME MODEL 20.5 DIOPTER) AND PATIENT OUTCOME WITH THE REPLACEMENT LENS, THE EVENT IS NO LONGER CONSIDERED REPORTABLE. NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 3012236936-2024-0003332. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A6: UNKNOWN/ASKED BUT UNAVAILABLE (ASKU). SECTION D6B: IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) EXPERIENCED A VERY SURPRISING HYPEROPIC RESULT, +1.75 -0.25 X 105 DURING A POST-OPERATIVE (OP) EXAM. THE LENS WAS EXPLANTED DURING SECONDARY PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858525 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention