BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF (R) IQ TORIC IOL CALCULATOR

    MDR report key: 3152631 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00598
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 24, 2016
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    PMA / PMN Number
    NA
    Removal / Correction Number
    MA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETE QUESTIONNAIRE HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A REFRACTIVE SURPRISE OF THE CYLINDER NOT BEING CORRECTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON, WHO INDICATED THE REFRACTIVE SURPRISE WAS THE RESULT FROM THE TORIC CALCULATOR. THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249260 ACRYSOF (R) IQ TORIC IOL CALCULATOR NA HQL ALCON LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other SN6AT7| MONARCH III HANDPIECE| MONARCH D CARTRIDGE