BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6134714 · Received November 30, 2016

    Report

    Report Number
    1119421-2016-01668
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    August 10, 2016
    Report Date
    January 12, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED IN AGE/DATE OF BIRTH, SEX, WEIGHT, DATE OF EVENT, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY AND CONCOMITANT MEDICAL PRODUCTS. THIS EVENT IS NO LONGER REPORTABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH THE OUTCOME. THE IOL WAS EXCHANGED DUE TO A REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT THE EVENT RESOLVED WITH TREATMENT. IN THE SURGEON'S OPINION THE IOL DID NOT CAUSE/CONTRIBUTE TO THE EVENT. HE EXPLAINS THAT THE PATIENT DECIDED AFTER SURGERY THAT SHE WANTED A DIFFERENT REFRACTIVE OUTCOME. SHE WAS INITIALLY TARGETED FOR DISTANCE BUT LATER DECIDED SHE WANTED NEAR VISION. THE IOL WAS REPLACED WITH ANOTHER LENS THAT WAS 2 DIOPTER DIFFERENT IN POWER. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS EVENT IS NO LONGER REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786846 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT4 12121695

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention