BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2932230 · Received January 25, 2013

    Report

    Report Number
    1119421-2013-00077
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 27, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    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 ADD¿L INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.(B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED AFTER A CAPSULE RUPTURE WAS NOTED. AN ANTERIOR VITRECTOMY WAS PERFORMED. THE IOL WAS REPLACED WITH A LENS IN THE ANTERIOR CHAMBER. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36176 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD./ HUNTINGTON SN6AT3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention