BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1894954 · Received November 5, 2010

    Report

    Report Number
    1119421-2010-01225
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    August 10, 2010
    Report Date
    October 8, 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
    TX, 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. ADDITIONAL INFO WAS REQUESTED ON 10/11/2010 AND 11/02/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE ON 10/11/2010 AND 10/13/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPERATING ROOM MANAGER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS USED AND REMOVED. IN A FOLLOW UP PHONE CALL, A NURSE REPORTED AN UNPLANNED VITRECTOMY WAS PERFORMED, NO FAULT OF THE LENS. ADDITIONAL INFO WAS RECEIVED VIA TELEPHONE FROM THE NURSE WHO REPORTED THE EYE WAS "TOO SOFT TO SUPPORT THE LENS." THE IOL WAS REPLACED WITH A DIFFERENT MODEL LENS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON MA60AC 10803155

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention