BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3370403 · Received September 13, 2013

    Report

    Report Number
    1119421-2013-00951
    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). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, IT WAS REPORTED THAT ONE EYE EXPERIENCED POSTOPERATIVE COMPLICATIONS (PUPILLARY BLOCK GLAUCOMA, WAVE-LIKE DEPOSITS AND FOLDS IN THE INTERFACE) AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462286 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other