BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALONID

    MDR report key: 513735 · Received February 20, 2004

    Report

    Report Number
    9610566-2004-00002
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    November 7, 2003
    Report Date
    February 20, 2004
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOXIC ENDOTHELIAL CELL DESTRUCTION SYNDROME [CORNEAL DISORDER NOS]. A HEALTH AUTHORITY REPORTED THAT PT, SUFFERING FROM ANGINA PECTORIS AND PARKINSON'S DISEASE, UNDERWENT RIGHT PHACOEMULSIFICATION, INCIPIENT CATARACT EXCISION AND INTRAOCULAR LENS IMPLANT DURING WHICH HYALURONIC ACID (HEALONID, 0.85ML, GMDN CODE 35907) WAS USED. AT THE TIME OF THE ADVERSE EVENT THE PT WAS ALSO IN THERAPY WITH THE FOLLOWING DRUGS: CALCIPOTRIOL FOR PSORIASIS, CYCLOPENTOLATE HYDROCHLORIDE, PHENYLEPHRINE, FLURBIPROFEN (OCUFEN) AND CHLORAMPHENICOL AS PREMEDICATION IN 2003, OXYBUPROCAINE (BENOXINATE HYDROCHLORIDE), CALCIUM CHLORIDE/SODIM ACETATE/MAGNESIUM CHLORIDE/SODIUM CITRATE/POTASSIUM CHLORIDE (ALCON BSS), LIGNOCAINE 0.5-1ML) FOR ANESTHESIA, POVIDONE IODINE (BETADINE) AND BETAMESTHASONE (BETNESOL). ON THE SAME DAY OF INTERVENTION, THE PT WAS DISCHARGED FROM THE HOSP AND THREE DAYS LATER, THEY DEVELOPED TOXIC ENDOTHELIAL CELL DESTRUCTION SYNDROME IN THE CORNEA. THE PT WAS TREATED WITH TOPICAL AND SYSTEMIC STEROIDS AND OCULAR HYPOTENSIVE DRUGS. AT THE TIME OF THIS REPORT THE PT HAD NOT RECOVERED. THE EVENT "TOXIC ENDOTHELIAL CELL DESTRUCTION SYNDROME" WAS CONSIDERED SERIOUS/INCIDENT AS PER INTERVENTION REQUIRED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL PERSONNEL, USER FACILITY, DISTRUBUTOR MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. CASE COMMENT: TOXIC ENDOTHELIAL CELL DESTRUCTION SYNDROME IS A RARE COMPLICATION OF INTRAOCULAR SURGERY. CORNEAL ENDOTHELIAL CELL TOXIC EFFECTS HAVE BEEN DEMONSTRATED EXPERIMENTALLY TO OCCUR WITH PRESURGICAL TOPICAL ANTISEPTIC SOLUTIONS, INTRAOCULAR IRRIGATING SOLUTIONS, HIGH CONCENTRATIONS OF INTRAOCULAR MEDICATIONS, ANTIBIOTICS IN CORNEAL STORAGE MEDIA, PRESERVATIVES IN MEDICATIONS, DETERGENT RESIDUES ON INSTRUMENTS, OR INTRAOCULAR AIR. CORNEAL EDEMA FOLLOWING OPHTHALMIC SURGERY ALSO CAN RESULT FROM MECHANICAL TRAUMA, HIGH INTRAOCULAR PRESSURE, OR INFLAMMATION. THEREFORE A COMPLICATION OF THE CATARACT SURGERY, RATHER THAN THE USE OF HEALONID IS A MORE PLAUSIBLE EXPLANATION FOR THE OCCURRENCE OF THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention