BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 1901937 · Received November 12, 2010

    Report

    Report Number
    1119421-2010-01252
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    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
    ME, US
    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 10/15/2010 AND 11/09/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING THREE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, THE HAPTICS WERE RIGID IN THE DISTAL AREA AND CAUSED THE CAPSULAR BAGS TO TEAR. THE IOLS WERE THEN IMPLANTED IN THE SULCUS. FOR THIS PT A VITRECTOMY WAS PERFORMED AND SHE EXPERIENCED AN ELEVATED INTRAOCULAR PRESSURE ON THE FIRST POSTOPERATIVE DAY. SHE WAS TREATED WITH MEDICATIONS FOR TWO MONTHS FOLLOWING THE PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MC60BD 10936505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention