BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINAR

    MDR report key: 12848995 · Received November 19, 2021

    Report

    Report Number
    2020664-2021-08155
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 19, 2021
    Manufacturer
    VIANT (LAKE REGION MEDICAL - ACCELLENT INC.)
    Product Code
    HQC
    PMA / PMN Number
    K844373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS DISCARDED AT THE FACILITY. NO LOT NUMBER WAS PROVIDED; THEREFORE, COMPLAINT HISTORY AND MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. THE PRODUCT SAMPLE WAS DISCARDED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A POTENTIAL CAUSE FOR METAL DEBRIS IN THE EYE IS CONTACT BETWEEN THE PHACO TIP AND A SECONDARY INSTRUMENT (E.G. A CHOPPER INSTRUMENT) INSERTED THRU THE SIDE PORT INCISION WHEN THE ULTRASONICS IS ACTIVATED. IMPROPER/INADEQUATE CLEANING MAY ALSO RESULT IN PARTICULATE MATTER ADHERING TO THE INSTRUMENT AND EXFOLIATION OF PARTICLES INTO THE SURGICAL FIELD. THE TITANIUM GRADE USED TO MANUFACTURE PHACO TIPS IS BIOCOMPATIBLE. THERE ARE CURRENTLY NO DOCUMENTED OR REPORTED COMPLICATIONS IN LITERATURE. THE TITANIUM GRADE USED TO MANUFACTURER PHACO TIPS IS BIOCOMPATIBLE. THERE ARE CURRENTLY NO DOCUMENTED OR REPORTED COMPLICATIONS IN LITERATURE. BASED ON INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. JOHNSON & JOHNSON WILL CONTINUE TO MONITOR THIS TYPE OF REPORTED EVENT PER GLOBAL COMPLAINT TRENDING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GLITTERING MATTERS WERE FOUND IN PATIENT'S EYE POSTOPERATIVELY; THE SURGEON SUSPECTED THE MATTERS WERE ORIGINATED FROM PHACO TIP USED DURING THE PROCEDURE. THE PHACO TIP HAD BEEN REUSED AND DISCARDED AT CUSTOMER SITE. THERE HAS BEEN NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740584 LAMINAR UNIT, PHACOFRAGMENTATION HQC VIANT (LAKE REGION MEDICAL - ACCELLENT INC.) OPOR3020L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown