BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2792211 · Received October 12, 2012

    Report

    Report Number
    1119421-2012-01274
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, IT WAS NOTED THAT THE PLASTIC FROM THE INTERNAL PART OF THE PACKAGE WAS "VIOLATED". ANOTHER TYPE OF LENS WAS USED WHICH DOES NOT CORRECT FOR ASTIGMATISM. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT6 12015404

    Patients

    Seq Age Sex Outcome Treatment
    1 Other