BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIZYME CLEANING TABLET

    MDR report key: 276114 · Received May 3, 2000

    Report

    Report Number
    2250023-2000-00001
    Event Type
    Injury
    Date Received
    May 3, 2000
    Date of Event
    February 1, 2000
    Report Date
    May 3, 2000
    Manufacturer
    CFH LABORATORIES, L.P.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SERIOUS INJURY INVOLVING ONE PERSON. A USER/PATIENT CALLED CIBA STATING THAT PT HAD RECEIVED A "LESION" IN BOTH EYES AS A RESULT OF USING UNIZYME A MONTH AGO. PT STATED THAT "THE DOCTOR DETERMINED IT WAS A SOLUTION RELATED INCIDENT THAT CAUSED THE DAMAGE TO THE LENS WHICH ULTIMATELY AFFECTED THE EYES." PT USED THE UNIZYME TABLETS IN A THERMAL UNIT, WHICH IS NOT APPROVED ACCORDING TO INSTRUCTIONS, AND SAYS AS A RESULT PT LENSES WERE DAMAGED WHICH ULTIMATELY AFFECTED PT EYES. PT EYES BECAME IRRITATED. PT REMOVED LENSES. THE IRRITATION PERSISTED. THE DOCTOR SUGGESTED AN INOFFICE PROCEDURE TO REMOVE THE LESIONS, BUT COULD NOT CONTINUE DUE TO THE PATIENT'S HYPERTENSION. THE DOCTOR PERSCRIBED TOBRADEX AND MAXITROL OINTMENT AND SUGGESTED NOT TO WEAR LENSES FOR A YEAR TO GIVE PT'S EYES A REST. AFTER REPEATED ATTEMPTS TO OBTAIN FOLLOW-UP INFORMATION THE STATUS OF THE PATIENT IS UNKOWN. PT DOES NOT RESIDE AT THE TELEPHONE NUMBER PROVIDED AND WOULD NOT REVEAL PT'S PHYSICIAN'S INFORMATION (NAME OR NUMBER) BECAUSE "HE WOULD NOT WANT TO BE INVOLVED; MD IS VERY BUSY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIZYME CLEANING TABLET LENS CARE LPN CFH LABORATORIES, L.P. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other