BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALONID GV

    MDR report key: 368857 · Received December 28, 2001

    Report

    Report Number
    9610566-2001-00025
    Event Type
    Injury
    Date Received
    December 28, 2001
    Date of Event
    December 1, 2001
    Report Date
    December 28, 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:01-3828-S. CROSS REFERENCE WITH 01-3829-S; 01-3830-S; 01-3831-S; 01-3833-S; 01-3834-S; 01-3835-SL 01-3836-S; 01-3837-S. A PHARMACIST REPORTED A CASE REGARDING THE FIRST OF A GROUP OF TEN PATIENTS WHO UNDERWENT CATARACT SURGERY IN AN OPHTHALMOLOGY DEPT. IN DECEMBER 2001, THE SURGERY WAS PERFORMED USING HEALON GV (HYALURONATE SODIUM ; BATCH 5000669). AT 5-DAY POST SURGERY CHECK, IT WAS NOTICED THAT THE PATIENT HAD 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. FUTHER INFORMATION IS BEING SOUGHT.

    Description of Event or Problem · 1

    FOLLOWO-UP 1/29/2002. THE FOLLOWING NEW INFO HAS BEEN PROVIDED THROUGH A TECHNICAL COMPLAINT INVESTIGATION REPORT: TWO REFERENCE SYRINGES FROM THE REPORTED LOT N WERE SENT TO THE CHEMICAL DEPT FOR PH ANALYSIS. THE RESULT WAS FOUND TO BE WITHIN THE SPECIFICATION LIMITS. LATER ON, VIVE UNOPENED BLISTERPACK SYRINGES, RETURNED FROM CUSTOMER STORAGE, WERE VISUALLY INSPECTED AND THEY DID NOT EXHIBIT ANY CLOUDY SOLUTION OR MFG DEFECTS. THE SYRINGES WERE SENT TO THE CHEMICAL DEP 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 OSMOLAITY. 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 SIGNFICANT DEVIATION WAS FOUND. NO EARLIER COMPLAINT HAS 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 TO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58742 HEALONID GV HYALURONATE SODIUM LZP PHARMACIA & UPJOHN, FYRISLUND NA 5000669

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other