BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1772312 · Received July 23, 2010

    Report

    Report Number
    1119421-2010-00857
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 23, 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
    DC, US
    Reporter Occupation
    OTHER

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 6/24/2010, 6/25/2010, 6/29/2010, 07/20/2010, AND 7/21/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 6/29/2010. ADD'L INFO WAS RECEIVED BY PHONE ON 7/20/2010 AND 7/21/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED); "CORNEAL EDEMA" (CORNEAL EDEMA). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A NURSE REPORTED, A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT WAS NOTED TO HAVE HAD A PREVIOUS LASIK PROCEDURE WITH ENHANCEMENT (PRE-EXISTING). IN A F/U PHONE CALL, THE SURGEON'S OFFICE INDICATED, THE IOL EXCHANGE HAD BEEN PERFORMED AND THE PT WAS EXPERIENCING CORNEAL EDEMA. THE PT WAS BEING TREATED WITH MEDICATIONS FOR THE CORNEAL EDEMA. 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 SN60WF 11029556

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PRED FORTE| ZYMAR