BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 4894446 · Received July 7, 2015

    Report

    Report Number
    9612169-2015-00550
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 29, 2015
    Report Date
    September 8, 2015
    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
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY A DOCTOR WHO INFORMED THE EVENT WAS NOT RESOLVED. NO MEDICATION, MEDICAL INTERVENTION OR HOSPITALIZATION WERE REQUIRED TO TREAT THE EVENT. PER THE SURGEON, THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE AFFECTED EYE WAS THE RIGHT ONE.

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED TWO CASES OF CENTRAL HAZE WHICH LOOKED LIKE PHIMOSIS OR CALCIFICATION AFTER SURGERY. AN ANTERIOR YAG TREATMENT MAY BE PERFORMED TO IMPROVE THIS. ANOTHER PHYSICIAN SUGGESTED IT PROBABLY CONCERNS A CASE OF CALCIFICATION (WITH REGARD TO LOWER VISION), NO PHIMOSIS (SINCE CENTER OPTIC REMAINS CLEAR WITH THAT) OR WHITENING INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440227 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 21114778

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other