BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1960228 · Received January 5, 2011

    Report

    Report Number
    1119421-2010-01487
    Event Type
    Other
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: CAUSE COULD BE INDENTED. ADDITIONAL INFO WAS REQUESTED ON 12/09/2010, 12/15/2010, AND 12/17/2010 BY PHONE, FAX, AND MAIL. TWO QUESTIONNAIRES WERE SENT TO REQUEST ADDITIONAL INFO. THE FIRST QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2010. THE SECOND QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTED TWO MODERATE SIZE GRANULAR DEPOSITS ON THE INTERNAL IOL SURFACE PERIPHERALLY, BUT "NOTHING NEAR VISUAL AXIS." HE REPORTED THAT HE ATTEMPTED TO REMOVE THE DEPOSITS, BUT WAS UNSUCCESSFUL AND DECIDED TO ROTATE THE IOL DURING THE SAME PROCEDURE, SO THE DEPOSITS WERE HIDDEN PERIPHERALLY UNDER THE UPPER LID, AWAY FROM THE VISUAL AXIS. HE ALSO STATED THAT THE DEPOSIT WAS "NOT DEBRIS PULLED INTO THE EYE". THE SURGEON REPORTED THAT THE PT WAS DOING "OK" WITH SOME CORNEAL EDEMA DUE TO MANIPULATION TO TRY TO REMOVE THE DEPOSITS. IN A FOLLOW-UP, THE SURGEON FURTHER CLARIFIED THAT THE DEPOSITS APPEAR TO BE INTRINSIC ON THE IOL. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRACULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other PROVISC