BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1250411 · Received December 3, 2008

    Report

    Report Number
    1119421-2008-00978
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 11/04/2008, 11/05/2008 AND 11/18/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED WHEN A SURGEON NOTED A HAPTIC WAS MISSING ON THE IOL AFTER INSERTION. THE SURGEON REPORTED THAT HE HAD TO ENLARGE THE INCISION TO EXCHANGE THE IOL. THE SURGEON FURTHER REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE CORNEAL EDEMA. THE SURGEON REPORTED THE PATIENT'S VISION HAS CORRECTED TO 20/20 WITH ONLY A SMALL PATCH OF EDEMA REMAINING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention