BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 434661 · Received December 24, 2002

    Report

    Report Number
    1119421-2002-00515
    Event Type
    Injury
    Date Received
    December 24, 2002
    Date of Event
    November 27, 2002
    Report Date
    November 27, 2002
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO WAS PROVIDED BY THE REPORTING SURGEON. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, SUTURED IN THE CILIARY SULCUS ON 10/24/2002. A PARS PLANA VITRECTOMY WAS ALSO PERFORMED. ON 11/6/2002 DURING A FOLLOW-UP EXAMINATION, THE SURGEON NOTED IRIS CAPTURE. THE IOL WAS RE-POSITIONED AFTER A TREATMENT OF MYDRIATICS. ON 11/26/2002 THE PT RETURNED TO THE SURGEON INDICATING HE NOTED THE IOL MOVING IN THE EYE. THE SURGEON OBSERVED A DETACHED HAPTIC DURING EXAMINATION AND THE IOL WAS EXPLANTED AND REPLACED ON 12/4/2002.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT A DETACHED HAPTIC WAS NOTED ONE MONTH FOLLOWING INITIAL INTRAOCULAR LENS IMPLANT SURGERY. THE HAPTIC HAD BEEN SUTURED IN PLACE. AS THE LENS WAS EXPLANTED, THE OTHER HAPTIC WAS CUT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON MA50BM 685845

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention