BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN PHACO HANDPIECE

    MDR report key: 11040129 · Received December 18, 2020

    Report

    Report Number
    3006695864-2020-00557
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 18, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MODEL NO. IS UNKNOWN AS IT WAS NOT PROVIDED, SERIAL NO. IS UNKNOWN AS IT WAS NOT PROVIDED, UNIQUE IDENTIFIER (UDI#) IS UNKNOWN AS SERIAL NO. WAS NOT PROVIDED, PHONE NUMBER (B)(4), MANUFACTURER DATE IS UNKNOWN AS SERIAL NO. WAS NOT PROVIDED. NO EVALUATION COULD BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE SERIAL NUMBER OF HANDPIECE WAS NOT PROVIDED; THEREFORE, THE MANUFACTURER RECORD COULD NOT BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, 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

    DURING PHACOEMULSIFICATION, THE PHACO HANDPIECE WAS NOT ABLE TO EXTRACT PART OF THE LENS, AND THE PATIENT WAS HOSPITALIZED. THERE WAS AN INCISION ENLARGEMENT OF THE MAIN CORNEAL INCISION AND A SUTURE WAS NEEDED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503959 SOVEREIGN PHACO HANDPIECE PHACO HANDPIECE HQC JOHNSON & JOHNSON SURGICAL VISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention