BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALONID GV

    MDR report key: 372191 · Received January 14, 2002

    Report

    Report Number
    9610566-2002-00002
    Event Type
    Injury
    Date Received
    January 14, 2002
    Report Date
    January 14, 2002
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    MRE
    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]. SPONTANEOUS DEVICE REPORT. A PHARMACIST REPORTED A CASE REGARDING THE FIRST OF TWO PATIENTS WHO UNDERWENT CATARACT SURGERY IN AN OPHTHALMOLOGY DEPARTMENT. ON A NOT SPECIFIED DATE, THE SURGERY WAS PERFORMED USING HEALONID GV (SODIUM HYALURONATE; BATCH 5002512) AND VANCOMYCIN (20 MICROGRAMS/L) IN 500 ML OF BALANCED SALT SOLUTION (BSS). AFTER THE SURGICAL INTERVENTION, THE PATIENT EXPERIENCED A CORNEAL DETERIORATION CONSISTING OF A DETERIORATION IN THE PATIENT'S VISION AND THE PATIENT'S VISION BECOMING MISTY. THE PATIENT IS UNDER TREATMENT WITH STEROIDS. THE OUTCOME IS UNKNOWN. THE REPORTING PHARMACIST STATED THAT THE HOSPITAL HAD SUSPENDED ALL FUTURE CATARACT OPERATIONS UNTIL THE INVESTIGATION WILL BE COMPLETE. BESIDES, ALTHOUGH AT PRESENT THE ONLY COMMON FACTOR AMONGST THE PHARMACEUTICALS PRODUCTS USED IN THE PATIENT IS HEALONID GV, THE HOSPITAL IS NOT PARTICULARLY IMPLICATING HEALONID GV AND ALL ASPECTS OF THE CATARACT OPERATION PROCEDURES ARE STILL UNDER INVESTIGATION. FURTHER INFORMATION IS BEING SOUGHT. CASE COMMENT: THERE IS A PLAUSIBLE TEMPORAL RELATIONSHIP BETWEEN THE ADMINISTRATION OF HEALONID GV (HYALURONATE SODIUM) AND THE OCCURRENCE OF THE REPORTED EVENTS. HOWEVER, THE FUNCTION OF VISCOELASTICS, SUCH AS HEALONID GV, IS TO PROTECT THE CORNEAL AND OCULAR STRUCTURE DURING SURGERY. CORNEAL DETERIORATION AND VISION DETERIORATION MAY OCCUR POST-OPERATIVELY; THE ETIOLOGY MAY BE A TOXIC CORNEAL REACTION OR A MECHANICAL TRAUMA DURING SURGERY. THE REPORT DOES NOT PROVIDE DETAILS OF THE SURGICAL PROCEDURE, AND WHETHER THERE WERE ANY COMPLICATION DURING SURGERY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENTS. THE PATIENT RECEIVED VANCOMYCIN AND BSS WHICH POSSIBLY COULD HAVE CONTRIBUTED THE EVENTS. FURTHER INVESTIGATIONS ARE CARRIED OUT AND UNTIL IS INFORMATION AVAILABLE A SOUND CAUSALITY ASSESSMENT CANNOT BE MADE. CORNEAL DETERIORATION AND VISTION DETERIORATION ARE EVENTS NOT LISTED IN THE CORE DATA SHEET OF HEALONID GV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALONID GV HYALURONATE SODIUM MRE PHARMACIA & UPJOHN, FYRISLUND NA 5002512

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R