BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR MULTIFOCAL TORIC

    MDR report key: 2230495 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00980
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OFFICE MANAGER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PT HAD SOME "CONCERNS" AND THE SURGEON BELIEVES LENS REPLACEMENTS WOULD BE REQUIRED. IN A F/U, THE OFFICE MANAGER CONFIRMED THAT THE LENSES WERE EXCHANGED FOR A DIFFERENT BRAND IOL. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ RESTOR MULTIFOCAL TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SND1T4 12004160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention