BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE BIFOCAL CONTACT LENSES

    MDR report key: 1132645 · Received August 22, 2008

    Report

    Report Number
    1033553-2008-00099
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    April 7, 2002
    Report Date
    August 22, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT. THE INITIAL REPORT INDICATED, THE PT WAS DIAGNOSED AND TREATED FOR ACANTHAMOEBA KERATITIS (AK). ADDITIONAL INFORMATION REVEALED THE PT DEVELOPED BILATERAL AK. THIS RECORD DOCUMENTS THE ADVERSE EVENT OD. THE PT WORE ACUVUE BIFOCAL CONTACT LENSES AND USED COMPLETE MPS BY AMO. THE INITIAL SYMPTOMS OCCURRED WHILE THE PT WAS IN OTHER COUNTRY. THE PT WAS HOSPITALIZED WITH DIAGNOSIS OF BILATERAL AK IN 2002. THE PT PRESENTED WITH BILATERAL INFILTRATION WITH HYPOPYON. INITIAL CORNEAL SCRAPING PERFORMED THE NEXT DAY, AND SHOWED PROBABLE ACANTHAMOEBA. THE PT WAS TREATED IN WITH NEOMYCIN, CHLORHEXIDINE, BETADINE 2%, ATROPINE, FLAGYL, TRADOL. THE TREATMENT WAS SUSPENDED THE FOLLOWING MONTH, DUE TO OCCULT BLOOD IN FECES. ON THE NEXT DAY, SCRAPING OF BILATERAL CORNEAS HAD NEGATIVE RESULTS. THE PT SIGNED OUT OF AMA FOUR DAYS LATER AND RETURNED TO THE US. THE PT WAS SEEN AT AN TERTIARY EYE CLINIC ON THE DAY BEFORE, AND DIAGNOSED WITH BILATERAL AK, THE PT HAD BILATERAL, STROMAL RING INFILTRATES, BILATERAL, CENTRAL STROMAL OPACITIES AND CORNEAL EDEMA. VA: OD 20/400, OS 20/125. THE PT WAS TREATED WITH CHLORHEXIDINE, ATROPINE, OCUFLOX AND DOXYCYCLINE. THE PT'S OD IMPROVED BUT THE OS WORSENED. THE VA WITH PINHOLE CORRECTION IN 2007 WAS 20/40 -2 OD. THE LAST INFORMATION RECEIVED IS THE RECORD FROM 11/07/07 INDICATING THE PT'S VA WITHOUT CORRECTION OD IS 20/80 MINUS. CORRECTED VA WAS NOT NOTED IN THAT REPORT. THE LOT HISTORY REVIEW REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, WILL REPORT WITHIN 30 DAYS. MDR EVENTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE BIFOCAL CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA 1453660186

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| S