BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 3113661 · Received May 10, 2013

    Report

    Report Number
    1119421-2013-00521
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE HAD TO SWITCH FROM A PHACOEMULSIFICATION AND ASPIRATION PROCEDURE TO AN EXTRACAPSULAR CATARACT EXTRACTION (EDDE) DUE TO A POSTERIOR CAPSULE TEAR DURING THE SURGICAL PROCEDURE. THE INCISION WAS ENLARGED TO PLACE A SULCUS FIXATION LENS. THE HAPTIC OF THE LENS WAS NOTED TO BE BROKEN DURING THE IMPLANT PROCEDURE. DURING A POSTOPERATIVE VISIT, THE SURGEON NOTED WHAT HE THOUGHT WAS FOREIGN MATERIAL IN THE ANTERIOR CHAMBER. THE PT WAS RETURNED TO SURGERY AND WHAT APPEARED TO BE FOREIGN MATERIAL TURNED OUT TO BE THE BROKEN HAPTIC FLOATING IN THE VITREOUS. THIS WAS REMOVED DURING THE SECONDARY PROCEDURE, THE LENS REMAINS IMPLANTED. THE SURGEON REPORTED THE PT'S HOSPITALIZATION WAS EXTENDED DUE TO THE SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207504 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON CZ70BD 12159076

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization