BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 6866560 · Received September 14, 2017

    Report

    Report Number
    9612169-2017-00175
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    January 25, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE IOL MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. 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

    (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WHO SEES A "SMUDGE" IN HIS VISION FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE PATIENT WENT FOR A SECOND OPINION ELSEWHERE, UNDERWENT A YAG LASER, HOWEVER, WITH NO IMPROVEMENT. THE REPORTING SURGEON NOTED A SUBTLE RETINA FINDING ON INFRARED FUNDUS PHOTOS THAT MAY EXPLAIN HIS SYMPTOMS. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647247 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21148238

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention