BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRSOF SINGLE-PIECE IOL

    MDR report key: 6823269 · Received August 28, 2017

    Report

    Report Number
    6823269
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    June 8, 2016
    Report Date
    August 23, 2017
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR ELECTIVE PHACOEMULSIFICATION WITH POSTERIOR CHAMBER INTRAOCULAR LENS IMPLANT OF THE RIGHT EYE. SURGERY WAS COMPLETED WITHOUT ANY KNOWN COMPLICATIONS BY A NON-EMPLOYED PROVIDER. THE PATIENT PRESENTED THE NEXT DAY FOR A FOLLOW-UP APPOINTMENT. AT THIS TIME AN EYELASH WAS NOTED TO BE TRAPPED UNDER HER LENS. SHE WAS BROUGHT BACK TO THE OR THAT SAME DAY, BY THE SAME PROVIDER. THE EYELASH WAS REMOVED WITH NO FURTHER COMPLICATIONS NOTED. THE IMPLANT RECORD CONTAINS THE FOLLOWING INFORMATION: T = 9.07; E = 21%. MODEL: SA60AT. POWER: 23.5D. LENGTH: 13.0MM. OPTIC: 6.0MM. EXP DATE: (B)(6) 2020. UV. A PCL. ACRSOF SINGLE PIECE 1OL. ALCON LABORATORIES, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605038 ACRSOF SINGLE-PIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES, INC SA60AT 12391229

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R