BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3142983 · Received May 30, 2013

    Report

    Report Number
    1119421-2013-00590
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    October 2, 2012
    Report Date
    April 24, 2013
    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
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD COULD NOT BE REVIEWED AS THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE ROOT CAUSE CANNOT BE DETERMINED. NOT ENOUGH INFO WAS PROVIDED FROM THE REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PT HAD INDUCED ASTIGMATISM. THE EVENT IS EXPECTED TO RESOLVE WITH LASIK TREATMENT. NO FURTHER INFO IS EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239812 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other LENSX LASER