BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 17889553 · Received October 6, 2023

    Report

    Report Number
    3012236936-2023-02562
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 11, 2023
    Report Date
    March 21, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474725614
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): 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, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL AND CORRECTED INFO: FURTHER INFORMATION WAS PROVIDED CLARIFYING THAT THE IOL WAS NOT IMPLANTED. THERE WAS NO PATIENT HARM AS A BACK UP LENS WAS USED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED OUTSIDE OF STANDARD OF CARE. THIS WAS A REGULAR CATARACT CASE. NO OTHER INFORMATION WAS PROVIDED. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H6: HEALTH EFFECT: IMPACT CODE: 4631 MORE COMPLEX SURGERY IS NO LONGER APPLICABLE. SECTION H6: HEALTH EFFECT: IMPACT CODE: 2199 TREATMENT NOT REQUIRED/NOT REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) PLUNGER ROD OVERRODE THE TRAILING HAPTIC AND CONSEQUENTLY THEN THE HAPTIC BROKE OFF. THE LENS WAS FULLY INSERTED THEN REMOVED AND REPLACED WITH A BACK UP LENS. IT IS UNKNOWN IF AN UNPLANNED INCISION ENLARGEMENT OR UNPLANNED VITRECTOMY WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238532 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU100 05050474725614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown