BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1914403 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01304
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED PAIN INSIDE HER LEFT EYE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATES HER VISION IS GOOD IN THE IMPLANTED (LEFT) EYE, BUT NOT AS GOOD AS IN THE RIGHT EYE. SHE WAS TOLD THAT HER PAIN IS DUE TO HER HISTORY OF DRY EYES AND BLEPHARITIS. SHE IS TAKING MEDICATIONS FOR THESE CONDITIONS, BUT STATES THEY DO NOT HELP. SHE HAS BEEN ADVISED TO GET PLUGS IN HER LOWER EYELIDS BUT HAS NOT DONE SO. TWO MONTHS FOLLOWING THE LENS IMPLANT, SHE WAS TREATED FOR A SKIN CONDITION WITH AN ANTIBIOTIC AND STATES THE SIDE OF HER FACE REMAINS SWOLLEN. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN60AT 10913773

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other TEARS| AMOXICILLIN| FISH OIL| YAZMIN