BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3951823 · Received July 2, 2014

    Report

    Report Number
    1119421-2014-00514
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 29, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE OF THE LENS OFF-AXIS. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR VISION. THE SURGEON REPORTED THAT THE IOL WAS TEN DEGREES OF AXIS. THREE WEEKS LATER HE RETURNED TO SURGERY WITH THE PATIENT AND REALIGNED THE IOL. THE REALIGNMENT DID NOT RESOLVE THE EVENT. THE PATIENT ALSO HAD UNEXPECTED SPHERICAL REFRACTIVE OUTCOME THAT WAS CAUSED BY A CALCULATION ERROR DUE TO AN INACCURATE FORMULA ENTRY, WHICH THE SURGEON DISCOVERED AFTER HE HAD REALIGNED THE IOL. THE SURGEON PLANS TO CONTINUE TO MONITOR THE PATIENT TO SEE IF THE FINAL VISION IS SATISFACTORY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386215 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN6AT3 12260781

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUOVISC ON