BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMFONY IOL

    MDR report key: 13251280 · Received January 12, 2022

    Report

    Report Number
    MW5106621
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    January 14, 2020
    Report Date
    January 10, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SYMFONY IOL IMPLANT RESULTED IN 3' BLIND ZONE NOT CORRECTABLE WITH GLASSES. CANNOT SEE ANYTHING WITH SYMFONY IOL EYE WITHIN HANDS REACH. RECALLED 2016? I'M USING +.50 BAUSH AND LOMB MULTIFOCAL CONTACT LENS IN SYMFONY EYE FOR DRIVING AND MIDRANGE. I USE +1.50 B AND L CONTACT LENS FOR CLOSE DETAILS. PLEASE APPROVE SULCOFLEX SUPPLEMENTAL IOL FOR CILIARY SULCUS IMPLANT TO CORRECT SYMFONY DEFECTIVE ERROR? THANKS. I HAVE DEFECTIVE SYMFONY IOL IN RIGHT EYE WITH 3' BLUR ZONE, CANNOT SEE ANY DETAILS WITHIN HANDS REACH. WAITING TO FIX BLUR ZONE BEFORE COMPLETING CATARACT SURGERY FOR LEFT EYE. INTERESTED IN CLINICAL STUDIES OF PHYSIOL FINEVISION TRIUMF TRIFOCAL EDOF FOR LEFT EYE, FOR FDA APPROVAL . WOULD APPRECIATE FDA APPROVAL OF SULCOFLEX SUPPLEMENTAL IOL FOR CILIARY SULCUS IMPLANT TO FIX SYMFONY BLUR ZONE IN RIGHT EYE?. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902214 SYMFONY IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT150

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other| S EYE DROPS PRESERVATIVE FREE MEGA3 REFRESH OPTIVE| FLAX OIL IN DIET FOR DRY EYES| OMEGAS 369| THERATEARS| THERATEARS PRESERVATIVE FREE EYE DROPS| VITAMIN SUPPLEMENTS