BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 1063729 · Received June 20, 2008

    Report

    Report Number
    1119421-2008-00465
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    March 26, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD 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 THIS LOT NUMBER. ADD'L INFO WAS REQUESTED ON 06/09/2008 AND 06/10/2008 VIA PHONE AND 05/22/2008 VIA FAX AND MAIL. THIS REPORT WAS MAILED TO FDA ON 06/20/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING BLURRY AND DISTORTED VISION AT ALL DISTANCES FOLLOWING AN INTRAOCULAR LENS (IOL) EXCHANGE PROCEDURE WHERE THE CONSUMER'S CAPSULAR BAG TORE. HE STATED THAT HE SEES AN OVERLAY OF LETTERS WHEN HE READS EVEN WITH USE OF HIS NEW GLASSES. HE ALSO REPORTED THAT HIS SURGEON HAS REMOVED THREE EXPOSED SUTURES SINCE HIS IOL EXCHANGE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON CZ70BD 863561

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other