BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1790934 · Received August 4, 2010

    Report

    Report Number
    1119421-2010-00872
    Event Type
    Other
    Date Received
    August 4, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 5, 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
    NJ, 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 REPORT 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

    ADVERSE EVENT(S): "SWOLLEN CORNEA, BLOODY EYE" (CORNEAL EDEMA); "PUPIL LARGER" (NO CODE AVAILABLE); "LENS HAD TURNED GREEN/HAZEL COLORED EYE TO A DARKISH GRAY COLOR" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAD NOTICED THAT THE LENS HAD TURNED HER "GREEN/HAZEL COLORED EYE TO A DARKISH GRAY COLOR". SHE ALSO REPORTED THAT SHE HAS A "SWOLLEN CORNEA, VERY BLOODY EYE (NOW ONLY BLOODY TOWARDS THE TOP PART OF THE EYE)" AND THAT THE PUPIL IS LARGER. AT HER ONE MONTH POSTOPERATIVE VISIT, HER SURGEON SAID THAT HE DID NOT KNOW WHAT CAUSED THE IRIS COLOR TO CHANGE AND THAT THE EYE LOOKED FINE. THE CONSUMER ALSO REPORTED THAT THE REDNESS ON THE WHITE PART OF THE EYE HAS DECREASED. SHE ALSO STATED THAT SHE SOUGHT A SECOND OPINION AND THAT SURGEON TOLD HER THAT HE ALSO DID NOT KNOW THE CAUSE OF CHANGE IN IRIS COLOR. 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 SN60WF 10845484

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other