BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON

    MDR report key: 286044 · Received July 13, 2000

    Report

    Report Number
    9610566-2000-00005
    Event Type
    Injury
    Date Received
    July 13, 2000
    Date of Event
    May 25, 2000
    Report Date
    July 13, 2000
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CORNEAL EPITHELIUM/STROMA OPACITY [CORNEAL OPACITY]. SPONTANEOUS SERIOUS REPORT.A PHYSICIAN REPORTED A PT WHO UNDERWENT CATARACT SURGERY AND IOL IMPLANTATION WITH THE USE OF HEALON 2000. IMMEDIATELY AFTER INFUSION, OF 0,2 ML HEALON AT THE ANTERIOR CAPSULAR INCISION, PT DEVELOPED CORNEAL EPITHELIUM/STROMA ( PARENCHYMA) OPACITY. POSTOPERATIVE SCRATCH TEST AND PATCH TEST REVEALED NEGATIVE REACTIONS. THE PT HAD NOT RECOVERED AT THE 6/8/00. THE REPORTING PHYSICIAN ASSESSED THE EVENT AS SERIOUS/PROLONGED HOSPITALIZATION AND THE CAUSALITY WITH HEALON AS UNASSESSABLE, AND COMMENTED: "IT WAS UNKNOWN WHETHER THE SYMPTOM HAD BEEN ALLERGY TO HEALON OR CAUSED BY OPERATION". INFO REGARDING TECH INVESTIGATION FROM THE MFR IS REQUESTED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL PERSONNEL, USER FACILITY, DISTRIBUTOR MFR OR PRIDUCT CAUSED OR CONTRIBUTED TO THE EVENT. F/U REPORT REC'D ON 6/28/00: THE TERM OF THE EVENT WAS CORRECTED TO CORNEAL OPACITY ( ALREADY RECORDED). ADD'L PT INFO, RELEVANT HISTORY, CONCURRENT THERAPY, AND FURTHER DETAILS OF THE CLINICAL COURSE WAS REPORTED. IN 2000, THE PT SUFFERING FROM MODERATE SENILE CATARACT WAS TO UNDERGO PHARMACOEMULSIFICATION PLUS IMPLANTATION OF IOL. HEALON 0.2 ML WAS INFUSED INTO ANTERIOR CHAMBER TO MAINTAIN THE CHAMBER IMMEDIATELY FOLLOWED BY MARKED CORNEAL OPACITY. THE PLANNED OPERATION WAS CHANGED TO EXTRACAPSULAR CATARACT EXTRACRATION AND COMPLETED. ON 5/26/00, ANTIINFLAMMATORY TREATMENT WAS CONTINUED. ON 6/2/00, CORNEAL STROMA (PARENCHYMA) OPACITY WAS STILL NOTED. IN CASE THE SYMPTOM IS NOT RESOLVED SPONTANEOUSLY, CORNEAL TRANSPLANTATION SHOULD BE CARRIED OUT. THE REPORTING PHYSICIAN ASSESSED THE EVENT AS SERIOUS/RISK FOR DEVELOPING DISABILITY/INCAPACITY ( AN MHW'S SERIOUSNESS CRITERION) AND THE CAUSALITY OF HEALON AS UN ASSESSABLE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE POSSIBILITY OF ALLERGIC REACTION TO HEALON CANNOT BE RULED OUT, CONSIDERING THE PT'S HISTORY OF ALLERGIC REACTION TO VARIOUS MEDICATIONS. HOWEVER, THE NEGATIVE TESTS WITH HEALON MAKES THE CAUSAL RELATIONSHIP BETWEEN HEALON AND THE EVENT AS UNASSESSABLE. CASE COMMENT: HEALON IS A VERY SAFE PRODUCT AND MOST OF THE ADVERSE REACTIONS ARE RELATED WITH THE INCOMPLETE REMOVAL OF THE PRODUCT DURING CATARACT SURGERY. IN THIS CASE, THE PT SUFFERS FROM PRE-EXISTING MEDICAL CONDITIONS THAT MAY BE RELATED WITH THE EVENT SUCH AS; DIABETES MELLITUS E STRONG ALLERGIES. THE COMPANY AGREES WITH THE REPORTING PHYSICIAN THAT THE POSSIBILITY OF ALLERGIC REACTION TO HEALON CANNOT BE RULED OUT, CONSIDERING THE PT'S HISTORY OF ALLERGIC REACTIONS TO VARIOUS MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON HYALURONATE SODIUM LZP PHARMACIA & UPJOHN, FYRISLUND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R