BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV

    MDR report key: 250620 · Received November 16, 1999

    Report

    Report Number
    9610566-1999-00028
    Event Type
    Injury
    Date Received
    November 16, 1999
    Date of Event
    August 17, 1999
    Report Date
    November 12, 1999
    Manufacturer
    PHARMACIA & UPJOHN AB
    Product Code
    HQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS INITIALLY RECEIVED FROM A PHYSICIAN AT AN AMBULATORY SURGICAL FACILITY REQUESTING INFO ON INTERACTIONS WITH HEALON GV AND LIDOCAINE DURING CATARACT EXTRACTION ( MFR. REPORT NUMBER 9610566-1999-00013). UPON FOLLOW-UP THE PHYSICIAN PROVIDED DETAILS FOR 14 PTS. THIS IS THE INITIAL REPORT FOR PT NINE. SINCE JUNE, 1999 TO PRESENT, 14 PT'S HAVE DEVELOPED ENDOPHTHALMITIS (12 STERILE) WITH THE USE OF HEALON GV AND LIDOCAINE. BOTH PRODUCTS WERE ADMINISTERED INTRAOCULAR (NOT AT THE SAME TIME). OTHER OPHTHALMOLOGISTS HAVE USED HEALON GV AND LIDOCAINE RETROBULBAR WITH NO PROBLEMS. THE CLINIC HAS INVESTIGATED THE PROBLEM. THE SAME PHACO MACHINES AND SAME MEDICATIONS WERE USED. ALL PT'S, WITHIN 12 HOURS POST-OP, DEVELOPED CLOUDING AND THEIR VISUAL ACUITY WAS DOWN TO LIGHT PERCEPTION. NO VITREOUS TAP WAS DONE. THE PHYSICIAN BELIEVED THE INTERACTION TO BE TOXIC IN NATURE. HEALON GV LOT AD58930 WAS USED. ALL PT'S WERE TREATED WITH STEROIDS AND SLOWLY REGAINED THEIR VISION. THE PHYSICIAN DID NOT FEEL THE EVENT TO BE LIFE-THREATENING, HOWEVER, DID BELIEVE THE EVENT TO BE SIGHT-THREATENING AND PERMANENT DAMAGE TO SIGHT IF TREATMENT HAD NOT BEEN INSTITUTED. THE REPORTING PHYSICIAN BELIEVES THE COMBINATION OF HEALON GV, LIDOCAINE, BENZALKONIUM CHLORIDE (FROM VARIOUS DROPS), AND THE ACRYLIC INTRAOCULAR LENSES USED BY THIS PHYSICIAN PRODUCE A TOXIC COCKTAIL WHICH LEADS TO THE EVENT. WHEN MIXED IN VITRO, THE REPORTING PHYSICIAN INDICATES THE ABOVE COMBINATION PRODUCES A DRASTIC CHANGE IN PH, WHICH POSSIBLY MAY RESULT IN THE EVENT. THE SURGEON HAS CHANGED TO VITREX AND REGULAR HEALON AND HAS NOT EXPERIENCED THE EVENT FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON GV Implant VISCOLASTIC HQJ PHARMACIA & UPJOHN AB NA AD58930

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R LIDOCAINE (EXP 09/02), BSS.