BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19295451 · Received May 11, 2024

    Report

    Report Number
    3012236936-2024-000137
    Event Type
    Malfunction
    Date Received
    May 11, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 11, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731752
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW, HEALTH EFFECT - CLINICAL CODE 4582 DID NOT UPDATE AFTER FILE CODING WAS UPDATED. CLINICAL CODE 4582 WAS UPDATED TO 4581 THEREFORE, THE UPDATED HEALTH EFFECT - CLINICAL CODE IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 4581 EYE ANATOMY ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-4 PATIENT WEIGHT: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION A-5 PATIENT ETHNICITY: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION A-6 PATIENT RACE: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION D-6A DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE, THEREFORE NOT EXPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. 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 REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) AND A HAPTIC WAS MISSING. THE PATIENT DID NOT HAVE SUPPORT FOR THE DIB00 IOL, THE IOL WAS REMOVED, AND A ZA9003 10.0 DIOPTER WAS IMPLANTED INTO THE PATIENT¿S OS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. ROOM TEMPERATURE BALANCED SALT SOLUTION (BSS) AND OPHTHALMIC VISCOSURGICAL DEVICE - VISCOELASTIC (OVD) WERE USED. THERE WERE NO DELAYS DURING THE PROCEDURE. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS PATIENT DID VERY WELL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970662 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female