BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALONID GV

    MDR report key: 372180 · Received January 14, 2002

    Report

    Report Number
    9610566-2002-00001
    Event Type
    Injury
    Date Received
    January 14, 2002
    Report Date
    January 14, 2002
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP 1/29/2002. THE FOLLOWING NEW INFO HAS BEEN PROVED THROUGH A TECHNICAL COMPLAINT INVESTIGATION REPORT: FIVE HEALON GV SYRINGES FROM THE RPEORTED LOT WERE TAKEN OUT FROM THE PLANT REFERENCE STORAGE AND VISUALLY INSPECTED. THEY DID NOT EXHIBIT ANY CLOUDY SOLUTION OF MFG DEFECT. THE SYRINGES WERE SENT TO THE CHEMICAL DEPT AND ANALYZED FOR: APPEARANCE, IDENTIFICATION, ZERO SHARE VISCOSITY, PH, MASS AVERAGE, RELATIVE MOLECULAR MASS, ASSAY FOR SODIUM HYALURONATE. THE RESULTS WERE FOUND TO BE WITHIN THE SPECIFICATION REQUIREMENTS/LIMITS. AN ANALYSIS WAS ALSO PERFORMED ON OSMOLALITY. THE RESULT WAS FOUND TO BE WITHIN THE LIMITS OF WHAT IS PHYSIOLOGICALLY ACCEPTED BY THE EYE. THE VISUAL INSPECTION OF REFERENCE SAMPLES EXHIBITED NO CLOUDY SOLUTION OR MFG DEFECT. THE BATCH DOCUMENTATION WAS REVIEWED AND NO SIGNIFICANT DEVIATION WAS FOUND. NO EARLIER COMPLAINT HAD BEEN REPORTED IN THE PAST ON THE BATCH UNDER EVAL. IN CONCLUSION, NO DEVIATION WAS FOUND IN THE INVESTIGATION THAT COULD EXPLAIN THE REASON FOR THIS COMPLAINT. FOLLOWUP 1/29/2002 ADDITIONAL INFO DOES NOT WARRANT A CHANGE IN THE CASE COMMENT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL PERSONNEL, USER FACILITY, DISTRIBUTOR, MFR, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    CORNEAL DETERIORATION [CORNEAL DISORDER NOS]. VISION DETERIORATION [VISUAL ACUITY REDUCED]. CASE DESCRIPTION: SPONTANEOUS DEVICE REPORT. A PHARMACIST REPORTED A CASE REGARDING THE SECOND 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 VISION 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 LZP PHARMACIA & UPJOHN, FYRISLUND NA 5002512

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R