BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3093744 · Received April 30, 2013

    Report

    Report Number
    1119421-2013-00464
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ALCON RESEARCH, LTD/ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED POSTOPERATIVE OUTCOME. ADD'L INFO WAS RECEIVED FROM THE SURGEON, WHO INDICATED THE EVENT RESOLVED WITH THE LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187165 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/ HUNTINGTON SN6AD1 12155336

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ANTI-INFLAMMATORY| ANTIBIOTIC DROPS| MONARCH CARTRIDGE| VISCOAT| HANDPIECE