BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3912647 · Received June 13, 2014

    Report

    Report Number
    1119421-2014-00452
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    March 6, 2014
    Report Date
    May 19, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE AS USED BUT AN UNAPPROVED HANDPIECE WAS USED WITH THE VISCOELASTIC. NOT ENOUGH INFORMATION WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE CARTRIDGE DESIGN WILL NOT WORK WITH THE HANDPIECE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ACCOUNT USED AN UNAPPROVED HANDPIECE. THE USE OF UNAPPROVED PRODUCTS MAY RESULT IN LENS DELIVERY DIFFICULTIES OR LENS DAMAGE. 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 QUESTIONNAIRE WAS RECEIVED ON 05/23/2014. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL MANAGER REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAD AN UNEXPECTED REFRACTIVE ERROR. THE LENS WAS EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IN A FOLLOW UP, THE SURGEON REPORTED MULTIPLE EYE DROP MEDICATIONS WERE USED TO TREAT THE PATIENT DURING THE EVENT. THE PATIENT'S SYMPTOMS RESOLVED WITH THE LENS EXCHANGE. AN UNAPPROVED HANDPIECE WAS USED DURING THE INITIAL IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349124 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/ HUNTINGTON SN6AT8 12179409

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHUGARCAINW| DUOVISC| MONARCH II HANDPIECE| VIGAMOX| EPI 1:1000| MONARCH D CARTRIDGE| BSS