BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1746287 · Received July 1, 2010

    Report

    Report Number
    1119421-2010-00764
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 06/04/2010, 06/07/2010, 06/22/2010, AND 06/25/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4). (B)(4). (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A TECHNICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO A REFRACTIVE SURPRISE. THE TECHNICIAN REPORTED THE PT HAD A HISTORY OF SALZMANN'S NODULES (PRE-EXISTING). THE TECHNICIAN REPORTED THE WRONG POWER IOL WAS USED DUE TO THE WRONG NUMBERS BEING USED IN THE CALCULATIONS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention