BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON 5

    MDR report key: 315258 · Received February 5, 2001

    Report

    Report Number
    9610566-2001-00005
    Event Type
    Injury
    Date Received
    February 5, 2001
    Date of Event
    January 7, 2001
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLUND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OCULAR HYPERTENSION (OCULAR HYPERTENSION). CASE DESCRIPTION: STUDY REPORT, PROTOCOL NUMBER: 840E-OPT-0071-015, PT NUMBER: 01-123, LOCAL REF NUMBER: 01-HEAL5-005. A PT WAS ENROLLED IN A HEALON 5 STUDY IN JAPAN. THE PT UNDERWENT A CATARACT SURGERY IN LEFT EYE IN DECEMBER 2000. UPG-96 (HEALON 5; 0.45 ML) WAS ADMINISTERED BY INTRAOCULAR ROUTE. IN JAN 2001, A CONJUNCTIVAL CONGESTION WAS NOTED THOUGH THE COURSE AFTER THE EYE SURGERY HAD BEEN CONTROLLED WELL. 2 DAYS LATER, INTRAOCULAR PRESSURE (IOP) IN PT'S LEFT EYE WAS 48 MMHG. AN ANTIHYPERTENSIVE DRUG (ORAL AND INTRAOCULAR) WAS PRESCRIBED FOR IOP. THE EVENT COULD BE CONSIDERED AS CORTICOSTEROID-INDUCED GLAUCOMA, THEREFORE STEROID EYE DROP WAS DISCONTINUED. HOWEVER, IOP WAS NOT DECREASED. THUS, A TREATMENT WITH ACETAZOLAMIDE, L-ASPARTATE POTASSIUM, OFLOXACIN, DORZOLAMIDE HCL, DICLOFENAC SODIUM, CARTEOLOL HCL AND ALDIOXA WAS INITIATED. TWO DAYS LATER, TIMOLOL MALEATE AND DIPIVEFRIN HCL WERE STARTED. THREE DAYS LATER, DIPIVEFRIN HCL WAS STOPPED AND TREATMENT WITH LOXOPROFEN SODIUM, BROMFENAC SODIUM HYDRATE AND MANNITOL WAS INTRODUCED. THE NEXT DAY, ALDIOXA, LOXOPROFEN SODIUM AND BROMFENAC SODIUM HYDRATE WERE DISCONTINUED. TWO DAYS LATER, MANNITOL WAS DISCONTINUED AND XALATAN WAS ADMINISTERED. THE REPORTING PHYSICIAN PLANNED TO PERFORM AN OPERATION FOR THE EVENT. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: IF THE EVENT HAD DEVELOPED DUE TO RESIDUAL DRUG AFTER THE SURGERY, IOP WOULD NOT HAVE INCREASED AFTER ONE WEEK FROM THE SURGERY. IF THE EVENT HAD BEEN CAUSED BY STEROIDS, THE PT SHOULD HAVE RECOVERED FROM THE EVENT ITSELF AFTER DISCONTINUATION OF STEROID DRUG. SINCE THE EVENT WAS STILL OBSERVED AFTER DISCONTINUATION OF STEROID AGENT, THE EVENT COULD NOT BE CONSIDERED AS A COTICOSTEROID-INDUCED GLAUCOMA. IT COULD NOT BE DENIED THAT TRABECULA HAD BEEN IRRITATED DURING THE OPERATION AND THIS FACT COULD HAVE INDUCED THE EVENT. FURTHER INFO IS EXPECTED. THE REPORTING PHYSICIAN CONSIDERED THAT THERE WAS A REASONABLE CAUSAL RELATIONSHIP BETWEEN THE ADMINISTRATION OF THE STUDY MEDICATION AND THE EVENT. CASE COMMENT: THE REPORTING PHYSICIAN CONSIDERED THAT A REASONABLE POSSIBILITY THAT THE EVENT (OCULAR HYPERTENSION) WAS RELATED WITH HEALON V, CANNOT BE DENIED. HOWEVER, OTHER EXPLANATIONS LIKE THE IRRITATION OR COMPROMISE OF THE TRABECULA DURING THE OPERATION MIGHT HAVE ALSO CONTRIBUTED OR CAUSE IT. ALTHOUGH THE LATEST PROVIDES A MORE LIKELY EXPLANATION FOR THE EVENT, THE POTENTIAL ASSOCIATION WITH HEALON V CANNOT BE RULED OUT. 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. THE PT UNDERWENT THE PLANNED TRABECULECTOMY ON JAN-2001 AFTER WHICH BOTH VISUAL ACUITY AND IOP WERE NORMALIZED WITHOUT THE USE OF ANTIHYPERTENSIVE DRUGS. AN ANTI-INFLAMMATORY AGENT WAS USED. THE PT WAS DISCHARGED FROM THE HOSP ON FEB-2001, COMPLETELY RECOVERED. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: "THE INITIAL CATARACT OPERATION ITSELF AND THE DRUGS USED IN THE OPERATION PROCESS CANNOT BE RULED OUT COMPLETELY AS CAUSED FOR THE EVENT, HOWEVER THE CAUSALITY IS STILL UNCLEAR. THE PT'S INTRAOCULAR PRESSURE AND VISUAL ACUITY HAVE REMAINED IN GOOD CONDITION AFTER THE CORRECTIVE TRABECULECTOMY".

    Description of Event or Problem · 1

    OCULAR HYPERTENSION (OCULAR HYPERTENSION). CASE DESCRIPTION: STUDY REPORT, PROTOCOL NUMBER: 840E-OPT-0071-015. A PT WAS ENROLLED IN A HEALON 5 STUDY IN JAPAN. THE PT UNDERWENT A CATARACT SURGERY IN LEFT EYE IN 2000. UPG-96 (HEALON 5; 0.45 ML) WAS ADMINISTERED BY INTRAOCULAR ROUTE. IN 2001, A CONJUNCTIVAL CONGESTION WAS NOTED THOUGH THE COURSE AFTER THE EYE SURGERY HAD BEEN CONTROLLED WELL. 2 DAYS LATER, INTRAOCULAR PRESSURE (IOP) IN PT'S LEFT EYE WAS 48 MMHG. AN ANTIHYPERTENSIVE DRUG (ORAL AND INTRAOCULAR) WAS PRESCRIBED FOR IOP. THE EVENT COULD BE CONSIDERED AS CORTICOSTEROID-INDUCED GLAUCOMA, THEREFORE STEROID EYE DROP WAS DISCONTINUED. HOWEVER, IOP WAS NOT DECREASED. THUS, A TREATMENT WITH ACETAZOLAMIDE, L-ASPARTATE POTASSIUM, OFLOXACIN, DORZOLAMIDE HCL, DICLOFENAC SODIUM, CARTEOLOL HCL AND ALDIOXA WAS INITIATED. TWO DAYS LATER, TIMOLOL MALEATE AND DIPIVEFRIN HCL WERE STARTED. THREE DAYS LATER, DIPIVEFRIN HCL WAS STOPPED AND TREATMENT WITH LOXOPROFEN SODIUM BROMFENAC SODIUM HYDRATE AND MANNITOL WAS INTRODUCED. THE NEXT DAY, ALDIOXA, LOXOPROFEN SODIUM AND BROMFENAC SODIUM HYDRATE WERE DISCONTINUED. TWO DAYS LATER, MANNITOL WAS DISCONTINUED AND XALATAN WAS ADMINISTERED. THE REPORTING PHYSICIAN PLANNED TO PERFORM AN OPERATION FOR THE EVENT. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: IF THE EVENT HAD DEVELOPED DUE TO RESIDUAL DRUG AFTER THE SURGERY, IOP WOULD NOT HAVE INCREASED AFTER ONE WEEK FROM THE SURGERY. IF THE EVENT HAD BEEN CAUSED BY STEROIDS, THE PT SHOULD HAVE RECOVERED FROM THE EVENT ITSELF AFTER DISCONTINUATION OF STEROID DRUG. SINCE THE EVENT WAS STILL OBSERVED AFTER DISCONTINUATION OF STEROID AGENT, THE EVENT COULD NOT BE CONSIDERED AS A COTICOSTEROID-INDUCED GLAUCOMA. IT COULD NOT BE DENIED THAT TRABECULA HAD BEEN IRRITATED DURING THE OPERATION AND THIS FACT COULD HAVE INDUCED THE EVENT. FURTHER INFO IS EXPECTED. THE REPORTING PHYSICIAN CONSIDERED THAT THERE WAS A REASONABLE CAUSAL RELATIONSHIP BETWEEN THE ADMINISTRATION OF THE STUDY MEDICATION AND THE EVENT. CASE COMMENT: THE REPORTING PHYSICIAN CONSIDERED THAT A REASONABLE POSSIBILITY THAT THE EVENT (OCULAR HYPERTENSION) WAS RELATED WITH HEALON V, CANNOT BE DENIED. HOWEVER, OTHER EXPLANATIONS LIKE THE IRRITATION OR COMPROMISE OF THE TRABECULA DURING THE OPERATION MIGHT HAVE ALSO CONTRIBUTED OR CAUSE IT. ALTHOUGH THE LATEST PROVIDES A MORE LIKELY EXPLANATION FOR THE EVENT, THE POTENTIAL ASSOCIATION WITH HEALON V CANNOT BE RULED OUT. 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
    4283 HEALON 5 HYALURONATE SODIUM LZP PHARMACIA & UPJOHN, FYRISLUND NA CSUT9101P

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R