BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1841623 · Received September 16, 2010

    Report

    Report Number
    1119421-2010-01015
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    July 1, 2006
    Report Date
    August 17, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE RPTR DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. A CASE OF SPONTANEOUS DISINSERTION OF A HAPTIC FROM 3-PIECE INTRAOCULAR LENS AFTER SCLERAL FIXATION. AUTHORS: TETSUYA MUTOH, YASUSHI UCHINO, YUKIHIRO MATSUMOTO, MAKOTO CHIKUDA. ENGLISH VERSION OF THE JOURNAL ARTICLE HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO A LITERATURE REPORT A PT HAD EXPERIENCED AN ACCIDENTAL BLOW TO THE LEFT EYE ON (B)(6) 2004. IN (B)(6) 2005, THE PT UNDERWENT A LENSECTOMY AND IOL IMPLANT BY SCLERAL FIXATION AS TREATMENT FOR THE INJURY. LATE IN (B)(6) 2006, THE PT COMPLAINED OF METAMORPHOPSIA. IN (B)(6) 2006 DURING AN EXAMINATION, THE HAPTIC OF THE IOL WAS NOTED TO HAVE DROPPED OUT FROM THE OPTIC. THE IOL HAD A TILT ON THE LEFT AND BELOW. THERE WAS NOT ABNORMALITY NOTED ON THE OPTIC MEDIA OR FUNDUS. THE PT UNDERWENT AN IOL EXCHANGE PROCEDURE. DURING THE EXCHANGE, IT WAS NOTED THE PT HAD A PARS PLANA VITRECTOMY PERFORMED DURING THE INITIAL IOL IMPLANT PROCEDURE. THE METAMORPHOPSIA WAS NOTED TO HAVE DISAPPEARED SHORTLY AFTER THE EXCHANGE PROCEDURE. A MONTH FOLLOWING THE EXCHANGE PROCEDURE, THE PT'S VISUAL ACUITY WAS NOTED TO BE APPROXIMATELY 20/25. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60BM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention