BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS ADVANCED INFUSION PACK

    MDR report key: 16542205 · Received March 14, 2023

    Report

    Report Number
    3012236936-2023-00607
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    February 14, 2023
    Report Date
    May 3, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    35050474700902
    PMA / PMN Number
    K203060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA AND ADDITIONAL INFORMATION: INITIALLY THE EVENT DATE WAS REPORTED AS 2/15/2023. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT OUT OF 6 PATIENTS WHICH WERE INITIALLY REPORTED TO HAVE EXPERIENCED ENDOPHTHALMITIS, FIRST 5 PATIENTS HAD SURGERY ON (B)(6) 2023 BETWEEN 9 AM AND 3 PM LOCAL TIME AND 6TH PATIENT HAD SURGERY ON (B)(6) 2023. SINCE THIS REPORT IS FOR PATIENT 1 OF 6 PATIENTS THE EVENT DATE HAS BEEN CORRECTED TO 2/14/2023. IT WAS ALSO REPORTED THAT THE HOSPITAL IS STRICT ABOUT THE CLEANING PROCESS AND HAS PERFORMED IN-HOUSE CULTURE TEST FOR ALL THE MATERIALS USED (INCLUDING PHACO PACK, OVD {OPHTHALMIC VISCOELASTIC DEVICES} AND BSS {BALANCED SALT SOLUTION} WITH SAME LOT NUMBER USED FOR ALL THESE SURGERIES, NOTHING WAS FOUND FROM THE CULTURE TEST SO NOT SURE IF IT WAS DUE TO PHACO HANDPIECE. REPORTEDLY IF IT WAS A CLEANING PROCESS ISSUE, SAME ISSUE MIGHT HAVE HAPPENED WITH PATIENTS WHO HAD CATARACT SURGERY IN THE SAME OPERATING ROOM AS DEVICE FROM ANOTHER MANUFACTURER WAS USED BY OTHER PHYSICIANS AFTERWARDS. BSS FROM ANOTHER MANUFACTURER WAS USED AND NEW BOTTLES WERE USED FOR EACH PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WHO HAD CATARACT SURGERY WITH VERITAS AI TUBING PACK WAS DIAGNOSED WITH ENDOPHTHALMITIS. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS 1 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036214 VERITAS ADVANCED INFUSION PACK UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC VRT-AI 60416304 35050474700902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other