BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE

    MDR report key: 16755378 · Received April 17, 2023

    Report

    Report Number
    3012236936-2023-00953
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 20, 2023
    Report Date
    June 28, 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
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION; IN THE INITIAL REPORT IT WAS NOT ADDED THAT THE CATALYS SYSTEM WAS ALSO CHECKED AS A RESULT OF THE SUCTION LOSS AND NO ISSUES WERE FOUND. THE CAUSE WAS RELATED TO THE LIQUID OPTICS INTERFACE. THE SYSTEM WAS PERFORMING TO SPECIFICATIONS. SECTION D10 MEDICAL PRODUCT: CATALYS SN: (B)(6). 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 D9: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 05/02/2023 DEVICE EVALUATION: ONE (1) OPENED LIQUID OPTICS INTERFACE WAS RECEIVED IN A BAG INCLUDING TYVEK LID CONFIRMING THE REPORTED LOT NUMBER. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT WERE PERFORMED AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2 A3, A4 AND A5: UNKNOWN/ NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SUCTION LOSS DURING FRAGMENTATION OCCURRED USING THE LIQUID OPTICS INTERFACE (LOI). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY AND/OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309437 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC 0180-1201 20937927 05050474609778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CATALYS SN: (B)(6)