BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON 0.6

    MDR report key: 477848 · Received August 11, 2003

    Report

    Report Number
    9610566-2003-00021
    Event Type
    Injury
    Date Received
    August 11, 2003
    Date of Event
    July 23, 2003
    Report Date
    August 11, 2003
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INTRAOCULAR PRESSURE INCREASED (TO 50 MMHG, LEFT EYE). A PHYSICIAN REPORTED A CASE REGARDING A PT (AGE AND GENDER UNKNOWN) WHO UNDERWENT A CATARACT SURGICAL INTERVENTION, IN THE LEFT EYE, IN WHICH SODIUM HYALURONATE (HEALON V 0.6ML AND PIONES 0.7ML) AND SODIUM HYALURONATE+CHONDROITIN SULFATE SODIUM (VISCOAT 0.5ML) WERE USED. SODIUM HYALURONATE (PIONES) AND SODIUM HYALURONATE+CHONDROITIN SULFATE SODIUM (VISCOAT) WERE ADMINISTERED TO THE PT WITH INTUMESCENT CATARACT WHEN CONTINUOUS CURVILINEAR CAPSULORHEXIS WAS PERFORMED. SINCE CRANIAL SAC WAS RUPTURED, AN INCISION WAS MADE USING SODIUM HYALURONATE (HEALON V). THEREAFTER THE PT RECEIVED PHACOEMULSIFCATION AND ASPIRATION AND AN INTRAOCULAR LENS WAS INSERTED USING SODIUM HYALURONATE (PIONES); VISCOELASTIC SUBSTANCES WERE SUCKED AND REMOVED AT FLOW RATE OF 25ML/MIN. THE NEXT DAY THE INTRAOCULAR PRESSURE INCREASED TO 50MMHG IN THE LEFT EYE AND THE PT WAS TREATED WITH LATANOPROST (XALATAN) AND CARTEOL HYDROCHLORIDE (MIKELAN). AT THE TIME OF THE PRESENT REPORT THE PT WAS UNDER OBSERVATION AND THE OUTCOME OF THE ADVERSE EVENT WAS UNKNOWN. FOLLOW-UP, THE FOLLOWING NEW INFO HAS BEEN PROVIDED. THE DOSES OF THE SUSPECT DRUGS USED DURING CATARACT EXTRACTION WERE CHANGED: SODIUM HYALURONATE (HEALON V 0.6ML) FROM 0.6ML TO 0.2ML, SODIUM HYALURONATE (PIONES) FROM 0.7ML TO 0.3ML AND SODIUM HYALURONATE+CHONDROITIN SULFATE SODIUM (VISCOAT) FROM 0.5ML TO 0.2ML. DURING THE INTERVENTION THE PT WAS CONCOMITANTLY TREATED WITH OXIGLUTATHIONE. THEY EXPERIENCED HEADACHE AFTER SURGERY, WHICH DISAPPEARED WITH ANODYNE. THE INTRAOCULAR PRESSURE INCREASED TO 51 MMHG IN THE LEFT EYE AND, AFTER LATANOPROST AND CARTEOLOL HYDROCHLORIDE TREATMENT, IT DECREASED, 2 DAYS LATER TO 13MMHG. THE PHYSICIAN ALSO COMMENTED: "THE PT HAD THE POTENTIAL OF DEVELOPING POSTOPERATIVE INTRAOCULAR PRESSURE INCREASED IRRESPECTIVE OF DRUG BECAUSE THEY HAD MATURE AND INTUMESCENT CATARACT AS UNDERLYING DISEASE. SODIUM HYALURONATE (HEALON V.06ML) WAS USED WITH LOW DOSAGE WHEN CONTINUOUS CURVILINEAR CAPSULORHEXIS WAS PERFORMED AND IT WAS UNLIKELY TO REMAIN IN THE ANTERIOR CHAMBER BECAUSE PHACOEMULSIFICATION AND ASPIRATION WAS PERFORMED WITH 40 TO 50 ML/MIN. HOWEVER THE CAUSALITY COULD NOT BE EXCLUDED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON 0.6 HYALURONATE SODIUM LZP PHARMACIA & UPJOHN, FYRISLUND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention| S