BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2814199 · Received October 26, 2012

    Report

    Report Number
    1119421-2012-01341
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT WAS NOTED TO HAVE 20/50 VISION ON THE FIRST POSTOPERATIVE DAY. A WEEK LATER, THE PT HAD FOLD IN DESCEMET'S AND OTHER ISSUES. THE PT ALSO DEVELOPMENT CORNEAL ABRASIONS. STEROIDS MEDICATION AND AN AMNIOTIC GRAFT WERE USED AS TREATMENT. THE PT WAS REFERRED TO A CORNEAL SPECIALIST, WHO BELIEVES THAT THE ISSUE IS MOST LIKELY RELATED TO MEDICATION AND THAT THE PT'S VISION MAY NEVER IMPROVE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention