BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3181431 · Received June 14, 2013

    Report

    Report Number
    1119421-2013-00665
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 20, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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 MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. NO FURTHER INFO IS EXPECTED. YAMAKAWA Y THE PHOTO OF DETACHED DESCEMET'S MEMBRANE - FROM 29TH OPHTHALMOLOGY PHOTO EXHIBITION (10). JAPANESE JOURNAL OF CLINICAL OPHTHALMOLOGY VOL. 67, NO. 2, 183. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE AN AUTHOR REPORTED A CASE OF DETACHED DESCEMET'S MEMBRANE DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE AUTHOR REPORTED THAT THE DETACHED DESCEMET'S MEMBRANE WAS NOTED AFTER THE IOL WAS INSERTED. AIR WAS INJECTED INTO THE ANTERIOR CHAMBER, BUT REATTACHMENT OF THE MEMBRANE WAS NOT PERFECT. DESCEMET'S MEMBRANE REMAINED ROLLED UP. THE PT'S VISUAL ACUITY WAS NOTED TO BE 1.0 (20/20) POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270716 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention