BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 4240951 · Received November 5, 2014

    Report

    Report Number
    1119421-2014-00871
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 7, 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
    NJ, 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 ADDITIONAL INFO BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS SPECIALIST REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PT REPORTED BLURRY VISION. THE LENS WAS NOTED TO BE DISLOCATED AND WAS EXCHANGED. IN A FOLLOW UP, A NURSE REPORTED THAT IN THE SURGEON'S OPINION, THE IOL WAS NOT TO BLAME FOR THE EVENT AND THE EVENT RESOLVED AFTER THE EXCHANGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709833 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT6 12227713

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention NEVANAC EYE DROP ((B)(6) 2014)| MONARCH III HANDPIECE| ORA SURGICAL SYS| MONARCH D CARTRIDGE| TOBRAMYCIN ((B)(6) 2014)| DUREZOL ((B)(6) 2014)