BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 1285956 · Received December 12, 2008

    Report

    Report Number
    1119421-2008-01007
    Event Type
    Other
    Date Received
    December 12, 2008
    Date of Event
    May 16, 2007
    Report Date
    November 12, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P810032
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 11/13/2008, 11/14/2008, 11/26/2008 AND 12/01/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED 12/04/2008. THIS REPORT WAS MAILED TO FDA ON: 12/12/2008.

    Description of Event or Problem · 1

    A CONSUMER'S SPOUSE REPORTED HER HUSBAND WAS EXPERIENCING BLURRED VISION AT NEAR AND DISTANCE, WITH VISION "LIKE LOOKING THROUGH WAX PAPER" FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT'S IOL IMPLANT SURGERY WAS PERFORMED IN 2000. THE PT HAS BEEN REFERRED TO A RETINAL SPECIALIST, WHO TOLD THE PT HE HAD POSSIBLE CYSTOID MACULAR EDEMA (CME). THE SPOUSE FURTHER REPORTED THE SURGEON HAD PRESCRIBED GLASSES TO HELP WITH VISUAL ACUITY. THE PT IS DIABETIC AND HAS HAD PREVIOUS LASER TREATMENT FOR DIABETIC RETINOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MC60CM 547214

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other