BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON GV PRO

    MDR report key: 14887540 · Received July 1, 2022

    Report

    Report Number
    3012236936-2022-01683
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 8, 2022
    Report Date
    January 12, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON GV PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON GV PRO IS NOT AN IMPLANTABLE DEVICE. THE DEVICE IS NOT RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PRODUCTS WERE NOT RETURNED HOWEVER TWO IMAGES OF THE ALLEGED PARTICLE WERE PROVIDED. ANALYSIS OF THE IMAGES DID NOT REVEAL ANY RELEVANT INFORMATION REGARDING THE COMPLAINT EVENT. AS A RESULT 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 D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: AUG. 24, 2022. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: BASED UPON THE VISUAL INSPECTION OF THE RETURNED PRODUCT, THERE IS NO INDICATION THAT THE CUSTOMER'S OBSERVATION IS DUE TO AN ISSUE WITH THE HEALON GV PRO PRODUCT. THEREFORE, THE CUSTOMER'S REPORT IS NOT CONFIRMED BY THIS INVESTIGATION AND NO PRODUCT DEFECT HAS BEEN OBSERVED. FURTHERMORE, ADDITIONAL INFORMATION IN THE FORM OF PHOTOGRAPHS PROVIDED BY THE CUSTOMER, COULD HAVE CONFIRMED MATERIAL FINDS IN THE EYE OF THE PATIENT. HOWEVER, THE MATERIAL FINDS FROM THE IMAGES WERE NOT SENT FOR THE INVESTIGATION AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. AN EXAMINATION OF THE PHOTOGRAPHS OF THE MATERIAL FINDS IN THE PATIENT'S EYE COULD INDICATE CORING OF THE RUBBER PERFORATION MEMBRANE DURING ACTIVATION OF THE PRODUCT AS A POSSIBLE ASSIGNABLE CAUSE. THE SIZE AND COLOR OF THE MATERIAL FINDS COULD BE COMMENSURATE WITH CORING OF THE RUBBER MEMBRANE. AS THE MATERIAL WAS NOT RETURNED, THEN THIS CANNOT BE CONFIRMED. CORING OF THE RUBBER MEMBRANE IS A KNOWN ISSUE. BASED ON THE INFORMATION OBTAINED, THERE IS NO INDICATION OF PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS PER GLOBAL COMPLAINT TRENDING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CUSTOMER USED HEALON GV PRO AND NOTICED WHITE SPECS IN THE PATIENT'S EYE. THE WHITE SPECS SEEMED TO COME OUT DURING IRRIGATION/ASPIRATION (I/A). THE LENS WAS IMPLANTED FINE. AS OF NOW, NO KNOWN VISUAL ISSUES. NO KNOWN PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097868 HEALON GV PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TG85ML UH31580 05050474651654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown