BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALONID GV

    MDR report key: 369103 · Received December 27, 2001

    Report

    Report Number
    9610566-2001-00021
    Event Type
    Injury
    Date Received
    December 27, 2001
    Date of Event
    December 1, 2001
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CORNEAL DETERIORATION[CORNEAL DISORDER NOS]. VISION DETERIORATION[VISUAL ACUITY REDUCED]. CASE DESCRIPTION: SPONTANEOUS DEVICE REPORT, LOCAL REF. N: 01-3832-S. CROSS REFERENCE WITH 01-3828-S; 01-3829-S; 0103830-S; 01-3831-S; 01-3833-S; 01-3834-S; 01-3835; 01-3836-S; 01-3837-S. A PHARMACIST REPORTED A CASE REGARDING THE FIFTH OF A GROUP OF TEN PATIENTS WHO UNDERWENT CATARACT SURGERY IN AN OPHTHALMOLOGY DEPT. IN 2001, THE SURGERY WAS PERFORMED USING HEALON GV. AT 5-DAY POST SURGERY CHECK, IT WAS NOTICED THAT THE PATIENT HAS DEVELOPED CORNEAL DETERIORATION, CONSISTING OF A DETERIORATION IN THE PATIENT'S VISION AND IN VISION BECOMING MISTY. THE OUTCOME WAS UNKNOWN. THE REPORTING PHARMACIST STATED THAT THE HOSPITAL HAD SUSPENDED ALL FUTURE CATARACT OPERATIONS UNTIL THE INVESTIGATION WILL BE COMPLETE. FURTHER INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58714 HEALONID GV HYALURONATE SODIUM LZP PHARMACIA & UPJOHN, FYRISLUND NA 5000669

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| S