BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11280665 · Received February 4, 2021

    Report

    Report Number
    2648035-2021-07199
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 4, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655492
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION THE LENS HAS BEEN EXPLANTED. TELEPHONE NUMBER: (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, 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. AN ATTEMPT HAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A STRESS LINE ON THE SAFT AND DEPOSIT ON THE LENS. THE SURGEON THOUGHT IT WAS A PIECE OF CORTEX, HOWEVER, THE SURGEON TRIED TO REMOVE IT WITHOUT ANY SUCCESS. THE LENS WAS FULLY INSERTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179152 TECNIS SIMPLICITY MONOFOCAL IOLS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655492

    Patients

    Seq Age Sex Outcome Treatment
    1