BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1669679 · Received April 22, 2010

    Report

    Report Number
    9612169-2010-00008
    Event Type
    Other
    Date Received
    April 22, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 2, 2010
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 HAS BEEN REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HALOS" (HALO). PRODUCT PROBLEM(S): "HAPTIC OF THE LENS HAS BEEN BROKEN' (BREAK [HAPTIC]), "IMPLANT IS OFF-CENTERED" (DISLODGED OR DISLOCATED [IOL (INTRAOCULAR LENS) IMPLANT]). A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE HAPTIC BROKE WHILE THE IOL CAME OUT OFF THE INJECTOR. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE IOL REMAINS IMPLANTED BUT OFF-CENTERED. THE SURGEON REPORTED THE PATIENT IS HAVING OCULAR DISCOMFORT WHICH WAS DESCRIBED AS HALOS (WHEN HER PUPIL IS DILATED) AND CAN SEE THE EDGE OF THE IOL. BECAUSE THE PATIENT'S VA IS "GOOD", NO EXPLANTATION IS PLANNED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 20918069

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other DUOVISC