BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3111345 · Received May 9, 2013

    Report

    Report Number
    1119421-2013-00512
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 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
    NY, 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 ARE NO OTHER COMPLAINTS REPORTED IN THE LOT. ADD¿L INFO WAS REQUESTED. B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAD POOR DISTANCE VISION. THE PATIENT HAD A HISTORY OF LASIK WHICH RESULTED IN THE OVERCORRECTION. THE LENS WAS EXCHANGED. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204690 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT3 17179315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention