BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 4040028 · Received August 19, 2014

    Report

    Report Number
    1119421-2014-00660
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 24, 2014
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND 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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADD'L INFO HAS BEEN REQUESTED BUT NOT REC'D TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT STILL HAD ASTIGMATISM AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON ALSO INDICATED THAT THE IOL WAS OBSERVED TO BE ROTATED SIX DAYS AFTER SURGERY. THE SURGEON WAS NOT ABLE TO CHECK THE IOL POSITION SINCE THE PUPIL DID NOT DILATE ENOUGH TO ALLOW OBSERVATION. ADD'L INFO HAS BEEN REQUESTED BUT NOT REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499632 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R