BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3370402 · Received September 13, 2013

    Report

    Report Number
    1119421-2013-00953
    Event Type
    Injury
    Date Received
    September 13, 2013
    Report Date
    August 14, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADDITIONAL INFO HAS BEEN REQUESTED. LIT REF: UGO DE SANCTIS, FRANCESCO DAMIANI, LUCA BRUSASCO, FEDERICO GRIGNOLO. REFRACTIVE ERROR AFTER CATARACT SURGERY COMBINED WITH DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY. AM J OPHTHALMOL 2013; 156:254-259. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, IT WAS REPORTED THAT ONE EYE WAS EXCLUDED FROM THE ANALYSIS BECAUSE DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL WAS IMPLANTED IN THE CILIARY SULCUS DUE TO A POSTERIOR OR CAPSULE RUPTURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461259 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other