BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16631740 · Received March 28, 2023

    Report

    Report Number
    3012236936-2023-00768
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 28, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636125
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). 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. HEALTH EFFECT - IMPACT CODE: 4625 SUTURES AND VITRECTOMY. MEDICAL DEVICE PROBLEM CODE: 4012 HAPTIC STUCK TO HAPTIC AND HAPTIC STUCK TO OPTIC. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER IMPLANTATION, THE DCB00 INTRAOCULAR LENS (IOL) LOOPS WERE STRONGLY ADHERED, REQUIRING SEQUENCES OF RISKY INTRAOCULAR MANEUVERS TO SEPARATE THEM. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE HAPTIC HELD TO THE HAPTIC AND ADHERED TO THE FACE ANTERIOR FACE OF THE OPTICAL ZONE. INSERTION OF THE LENS MANIPULATOR KLUGEN HOOK BY THE PARACENTESIS ASSOCIATED WITH THE SEIZURE OF THE HANDLES WITH THE FORCEPS UTRATA AND EXECUTION OF MOVEMENT OF THE OPPOSING FORCE. THERE WAS NO INCISION ENLARGEMENT AND NO SERIOUS PATIENT INJURY HOWEVER SUTURE(S) AND VITRECTOMY WERE REQUIRED. IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427498 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636125

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention