BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 3771008 · Received December 18, 2013

    Report

    Report Number
    1119421-2013-01234
    Event Type
    Injury
    Date Received
    December 18, 2013
    Report Date
    November 27, 2013
    Manufacturer
    ALCON RESEARCH, LRD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 MANUFACTURING DOCUMENTATION. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE FOUND IT HARD TO INJECT THE LENS. HE APPLIED PRESSURE TO THE INJECTOR AND THE LENS SHOT OUT RUPTURING THE POSTERIOR CAPSULAR BAG. THE SURGEON REMOVED THE IOL AND REPLACED IT WITH A DIFFERENT ONE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664022 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LRD./ HUNTINGTON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other