BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2792231 · Received October 12, 2012

    Report

    Report Number
    1119421-2012-01282
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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 MFG DOCUMENTATION. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THEY WERE UNABLE TO RELEASE THE IOL FROM THE FORCEPS INTO THE SULCUS. THE PT EXPERIENCED DAMAGE IN THE CAPSULAR BAG AND AN ANTERIOR VITRECTOMY WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention