BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12163204 · Received July 13, 2021

    Report

    Report Number
    2648035-2021-08108
    Event Type
    Injury
    Date Received
    July 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531765
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS RIGHT AFTER THE SURGERY ON (B)(6) 2019. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS 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 WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS THE PATIENT HAD NEGATIVE DYSPHOTOPSIA THAT SHE COMPLAINED OF TEMPORAL ARC IN HER VISUAL FIELD. THE SYMPTOM FIRST BECAME AWARE RIGHT AFTER THE INITIAL SURGERY. PARS PLANA VITRECTOMY WAS PERFORMED AND ANOTHER COMPETITOR LENS WAS PLACED AS THE REPLACEMENT LENS. THERE WAS NO OTHER INJURY TO THE PATIENT AND THE OUTCOME OF THE SURGERY WAS EXCELLENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056689 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531765

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention