BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3770955 · Received December 19, 2013

    Report

    Report Number
    1119421-2013-01244
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    October 8, 2013
    Report Date
    November 22, 2013
    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
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    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. 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 ADD'L INFO BY PHONE, FAX AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE IS EXPERIENCING DIFFICULTY WITH HER ACTIVITIES OF DAILY LIVING. AS A RESULT, SHE HAS DIFFICULTY WITH MOBILITY ISSUES AND SHE HAS BLURRED NEAR AND INTERMEDIATE VISION PROBLEMS. THE CONSUMER ALSO REPORTED THAT SHE HAD PERIPHERAL AND TEMPORARY BLOCK IN HER VISUAL FIELD RIGHT AFTER THE PROCEDURE,BUT THAT IT HAS RESOLVED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667710 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD./ HUNTINGTON SN6AT3 12159655

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other UNK.