BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1021082 · Received March 27, 2008

    Report

    Report Number
    1119421-2008-00176
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER REPORTS IN THE LOT. ADD'L INFO WAS REQUESTED ON 03/03/2008 BY MAIL AND ON 03/03/2008, 03/10/2008 AND 03/14/2008 BY PHONE.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT HAD A DECREASE IN VISUAL ACUITY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED HE NOTICED THE ANTERIOR SURFACE OF THE LENS LOOKED LIKE IT HAD DEGENERATED WHEN HE VIEWED IT UNDER THE SLIT LAMP. HE REFERRED TO ITS APPEARANCE AS LOOKING LIKE A PETRI DISH IN WHICH MATERIAL HAD GROWN IN THE CENTER. AN ADD'L SURGICAL PROCEDURE WAS PERFORMED (DETAILS NOT PROVIDED). THE PT WAS REPORTED TO HAVE RECOVERED 100% OF HIS VISION. THE IOL REMAINS IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60BM 904019

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention