BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVISC

    MDR report key: 2504877 · Received March 23, 2012

    Report

    Report Number
    1119279-2012-00066
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 23, 2012
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AT B+L FOR EVAL. A BATCH RECORD REVIEW DETERMINED THE COMPONENTS (SYRINGES AND CANNULA) LOTS USED FOR THIS PRODUCT MET ALL SPECS. NO ANOMALIES WERE IDENTIFIED IN THE BATCH RECORD THAT PERTAINS TO THE SYRINGE OR CANNULA LUER LOCK FEATURE. THE LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THIS EVENT IS PERFORMING WITHIN THE ANTICIPATED SEVERITY AND OCCURRENCE LEVELS AS DEFINED PER THE RISK ANALYSIS DOCUMENTATION. AN INVESTIGATION INTO THIS EVENT HAS BEEN OPENED TO EVALUATE POTENTIAL PRODUCT AND/OR INSTRUCTIONAL IMPROVEMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA COULD NOT BE PROPERLY CONNECTED TO THE SYRINGE AND DURING USE OF THE PRODUCT, THE PT MOVED AND THE CANNULA DETACHED FROM THE SYRINGE. THE DETACHED CANNULA PUNCTURED THE IRIS AND CAPSULE. A VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMVISC SUGICAL VISCOELASTIC MATERIAL LZP LIFECORE BIOMEDICAL, LLC 59081L 023886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other