BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2894778 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01609
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 26, 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
    TX, US
    Reporter Occupation
    OTHER

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CLINIC COORDINATOR REPORTED AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON WHO REPORTED THE LENS WAS EXCHANGED AND EVENT RESOLVED. THE SURGEON FURTHER EXPLAINED THAT THE INITIAL LENS INDUCED SIGNIFICANT ASTIGMATISM. HE ALSO INDICATED HE SUSPECTS THE PT HAD AN UNUSUAL CURVATURE OF POST-CORNEAL SURFACE. ADDITIONAL INFO INDICATED THE USE OF UNAPPROVED VISCOELASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT8 12105749

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention MONARCH CARTRIDGE C| AMVISC