BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 15820938 · Received November 17, 2022

    Report

    Report Number
    3012236936-2022-02869
    Event Type
    Injury
    Date Received
    November 17, 2022
    Report Date
    November 17, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474709935
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER AND WEIGHT: UNKNOWN, ASKED BUT INFORMATION WAS NOT PROVIDED. DATE OF EVENT: THE EXACT DATE IS UNKNOWN, THE BEST ESTIMATE IS BETWEEN OCT 18, 2022 AND OCT 25, 2022. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. PHONE NUMBER: 098-987-4004. THE DEVICE WAS NOT RETURNED 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. HEALTH EFFECT CLINICAL CODE: 2138 UNEXPECTED POSTOP REFRACTION, 2138 VISION LOSS (NOS) : VISUAL ACUITY REDUCED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO HAD UNDERGONE IMPLANTATION IN THE LEFT EYE COMPLAINED THAT THEIR VISION STILL HAD NOT RECOVERED, BLURRED VISION AND DECREASED VISUAL ACUITY REPORTED. PREOPERATIVE LEFT EYE VISION (LV) WAS 0.4 (0.5 P × S+1.00 C-0.50 A X 95°), BUT POSTOPERATIVE VISION HAD WORSENED TO LV: 0.08 P (0.08 × S+0.50 C-0.25 AX170°) IN THE THIRD POSTOPERATIVE DAY. IT WAS INDICATED THAT THE PATIENT HAS HAD NO HISTORY OF DISEASES LEADING TO REDUCED VISION. NO DISEASES, NO MACULOPATHY ALTHOUGH SOFT EXUDATE WAS OBSERVED AT THE FUNDUS REPORTED. POSTOPERATIVE INFLAMMATION REPORTED AS THE SAME LEVEL AS REGULAR SURGERY. NO OPTIC NERVE ABNORMALITY REPORTED. THE LENS REMAINS IMPLANTED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773569 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474709935

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other