BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON GV PRO

    MDR report key: 15332675 · Received August 31, 2022

    Report

    Report Number
    3012236936-2022-02161
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    June 29, 2022
    Report Date
    March 17, 2023
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474651654
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH,WEIGHT, AND ETHNICITY: UNKNOWN; REQUESTED BUT NOT PROVIDED. IF IMPLANTED; GIVE DATE: NOT APPLICABLE AS THE OVD (OPHTHALMIC VISCOELASTIC DEVICE) IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE OVD (OPHTHALMIC VISCOELASTIC DEVICE) IS NOT AN IMPLANTABLE DEVICE. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER ON: NOV 10, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: THE COMPLAINT SAMPLE CONSISTED OF THE GLASS CYLINDER WITH THE PLUNGER ROD ATTACHED TO IT. APPROXIMATELY 0.5ML EXPELLABLE HEALON SOLUTION REMAINED IN THE GLASS CYLINDER. A LARGER AIR BUBBLE WAS OBSERVED IN THE HEALON GV PRO SOLUTION. THERE WAS APPROXIMATELY 0.5ML OF EXPELLABLE HEALON GV PRO SOLUTION LEFT IN THE GLASS CYLINDER. THE CYLINDER HOLDER, PERFORATION NEEDLE, CANNULA, BLISTER TRAY, PRODUCT BOX AND DFU WERE NOT RETURNED. A PHOTO ANALYSIS OF PHOTO PROVIDED BY THE CUSTOMER REVEALED INDICATED THAT THE REPORTED DEVICE PROBLEM CODE OF "DC-FOREIGN MATERIAL - LOOSE" IS CORRECT. THE SOLUTION WAS CLEAR AND FREE FROM PARTICLES OR MATERIAL FINDS WHICH COULD EXPLAIN THE CUSTOMER'S OBSERVATION AND THE REPORTED DEVICE PROBLEM CODE OF "DC-FOREIGN MATERIAL - LOOSE". NO REMARKS OR SIGNS OF DAMAGED SILICON COATING OR DAMAGED GLASS CYLINDER. RUBBER PLUNGER SURFACE WAS FREE FROM PARTICLES OR MATERIAL FINDS WHICH COULD EXPLAIN THE CUSTOMER'S OBSERVATION AND THE REPORTED DEVICE PROBLEM CODE. NO SIGNS OF CORING ON THE OUTER SURFACE OF THE RUBBER MEMBRANE WERE OBSERVED. THE INNER SURFACE OF THE RUBBER MEMBRANE LOOKS NORMAL. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE COMPLETE SYRINGE WAS NOT RETURNED FOR THE INVESTIGATION. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE SPECKS WERE NOTICED IN THE EYE WHILE USING THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD). ALL WHITE SPECKS WERE SUCCESSFULLY REMOVED FROM THE EYE WITH IRRIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832524 HEALON GV PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TG85ML UJ31020 05050474651654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown