BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1 PIECE IOL

    MDR report key: 12264431 · Received August 2, 2021

    Report

    Report Number
    2648035-2021-08228
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 6, 2021
    Report Date
    August 2, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531833
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: NOT APPLICABLE SINCE LENS REMAINS IMPLANTED, NOT EXPLANTED. PHONE NO.: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, 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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DOCTORS COMPLAINED ABOUT A MICROCRACK FOUND AFTER IMPLANTATION OF THE LENS, DURING THE OPERATION. THE CRACK IS LOCATED PARALLEL TO THE PLACE OF TRANSITION OF THE HAPTICS TO THE OPTICS, NOT ON THE OPTICAL ZONE. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. MATERIAL NOT AVAILABLE FOR INVESTIGATION. NO PATIENT INJURY HAS BEEN REPORTED SO FAR. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155469 TECNIS 1 PIECE IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531833

    Patients

    Seq Age Sex Outcome Treatment
    1