BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID OPTICS INTERFACE

    MDR report key: 16969761 · Received May 19, 2023

    Report

    Report Number
    3012236936-2023-01282
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 25, 2023
    Report Date
    July 14, 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
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 06/14/2023 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES SECTION H6; TYPE OF INVESTIGATION - 10, 3331, 4109 SECTION H6; INVESTIGATION FINDINGS - 213 SECTION H6; INVESTIGATION CONCLUSIONS - 67 DEVICE EVALUATION: ONE (1) OPENED LOI WAS RECEIVED WITHIN A ZIP-SEAL BAG WITH ACCOMPANYING PAPERWORK INDICATING THE REPORTED LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED DID NOT REVEAL ANY OBVIOUS DEFECT OR DAMAGE. FUNCTIONALITY TESTS WERE PERFORMED, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL 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. H3 OTHER TEXT: SEE H10.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A1: (B)(6). SECTION A2: (B)(6) 1951 - 71 YEARS OLD. SECTION A3: FEMALE. SECTION A4: 120 POUNDS. SECTION A5: WHITE/AMERICAN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY WERE UNABLE TO FIXATE AND LOST SUCTION HOWEVER, UNSURE IF THIS OCCURRED PRIOR OR AFTER LASER FIRING. THE LASER PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY OR SURGICAL INTERVENTION NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075464 LIQUID OPTICS INTERFACE OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC 0180-1201 21365062 05050474609778

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female CATALYS SN (B)(6).