BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3960101 · Received July 17, 2014

    Report

    Report Number
    1119421-2014-00545
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ALCON MANUFACTURING, LTD. HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THAT THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED WITH THE HANDPIECE. TWO VISCOELASTIC DEVICE WERE USED; HOWEVER, ONLY ONE OF THE VISCOELASTIC DEVICES IS QUALIFIED FOR USE WITH THIS LENS/CARTRIDGE/HANDPIECE COMBINATION. NOT ENOUGH INFORMATION WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE ADMINISTRATOR REPORTED A PATIENT WITH AN UNEXPECTED OUTCOME, BLURRY VISION AND ANISOMETROPIA FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS WAS EXCHANGED TWO WEEKS LATER FOR THE SAME LENS MODEL, ONE DIOPTER DIFFERENCE IN POWER. IN A FOLLOW UP, THE NURSE ADMINISTRATOR REPORTED THAT THE EVENT RESOLVED FOLLOWING THE IOL EXCHANGE PROCEDURE. SHE ALSO REPORTED A POSTERIOR CAPSULE OPACITY (PCO) WAS OBSERVED PRIOR TO THE LENS EXCHANGE PROCEDURE. THE SURGEON INDICATED THE USE OF AN INCORRECT VISCOELASTIC DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417820 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. HUNTINGTON SN6AT6 12204628

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention MONARCH D CARTRIDGE| PROVISC| AUTOSERT HANDPIECE| VISCOAT| LENSX LASER