BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFOCAL IOLS

    MDR report key: 8468150 · Received April 1, 2019

    Report

    Report Number
    9614546-2019-00282
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    BRAND NAME: UNKNOWN/NOT PROVIDED. (B)(4). MODEL NUMBER: UNKNOWN/NOT PROVIDED HOWEVER IT WAS NOTED THE LENS MODEL IS EITHER A SYMFONY OR SYMFONY TORIC. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. CATALOG#: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. PMA/510(K) #: P980040 IS PROVIDED AS THE COMPLAINT PRODUCT IS EITHER A SYMFONY OR SYMFONY TORIC MODEL LENS. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE IS NOT RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THERE WAS NO MODEL/ SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). 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 EXCHANGE FROM EITHER A SYMFONY OR SYMFONY TORIC INTRAOCULAR LENS (IOL) TO A ZCT150 TORIC MONOFOCAL IOL WAS PERFORMED DUE TO THE PATIENT EXPERIENCING HALO AND GLARE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262694 MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention