BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE

    MDR report key: 16877376 · Received May 5, 2023

    Report

    Report Number
    3012236936-2023-01109
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    September 13, 2022
    Report Date
    June 12, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    UDI-DI
    05050474609778
    PMA / PMN Number
    K170322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3: DEVICE EVALUATED BY MANUFACTURER: NO DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE RGA (B)(4) WAS RECEIVED AT JJSV IRVINE ON 05/11/2023. THE CONTENTS OF THE PACKAGE WERE RECEIVED LOOSE WITHIN A BAG. INDIVIDUAL LIQUID OPTICS INTERFACE (LOI) COMPONENTS COULD NOT BE ASSOCIATED WITH THEIR CORRESPONDING COMPLAINT EVENTS OR LOT NUMBERS. PRODUCT TESTING CANNOT BE PERFORMED. PLEASE NOTE THAT THE INFORMATION REPORTED IN SECTIONS D2 (COMMON DEVICE NAME), H.6 (HEALTH EFFECT -CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE) AND SECTION G.1 (MANUFACTURER CONTACT E-MAIL) IS INFORMATION THAT REMAINS UNCHANGED FROM THE INITIAL EMDR REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE INTERFACE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE INTERFACE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. DEVICE EVALUATION: THE INTERFACE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTERFACE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SUCTION LOSS OCCURRED DURING LASER FIRE. NO PATIENT INJURY WAS REPORTED AND THE LASER PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER DETAIL WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678229 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC 0180-1201 20198069 05050474609778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CATALYS S/N:(B)(6).