BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 4132687 · Received September 24, 2014

    Report

    Report Number
    1119421-2014-00744
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ALCON REASEARCH . LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA; THE LENS REMAINS IMPLANTED. THE FILE INDICATED THE USE OF A CARTRIDGE AND A HANDPIECE. SPECIFIC MODELS WERE NOT PROVIDED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE CARTRIDGE AND HANDPIECE LOT BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED REFRACTIVE OUTCOME FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. THE SURGEON ALSO REPORTED THAT POSTOPERATIVELY, THE LENDS ROTATED AND WAS OFF AXIS BY 15 DEGREES. THE SURGEON PERFORMED AN ADDITIONAL PROCEDURE TO REALIGN THE LENS, BUT THERE WAS NO IMPROVEMENT IN THE RESULT. THE SURGEON REPORTED SHE RECALCULATED THE MEASUREMENTS AND THE CORRECT IOL WAS USED. THE SURGEON STATED SHE HAS MANAGED TO FLIP THE PATIENT'S AXIS AND LEAVE HER WITH +2.00 ASTIGMATISM IN THE OPPOSING PLANE. THE SURGEON ALSO NOTED THAT THE PATIENT HAS SOME CORNEAL SURFACE DISEASE AND HAS TREATED IT MORE AGGRESSIVELY, BUT THERE HAS BEEN NO IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593597 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON REASEARCH . LTD/HUNTINGTON SN6AT8 12288639

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention RESTATIS| ARTIFICIAL TEARS| HEALON GV| MONARCH CARTRIDGE AND HANDPIECE