BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 643526 · Received October 28, 2005

    Report

    Report Number
    2023826-2005-01507
    Event Type
    Injury
    Date Received
    October 28, 2005
    Date of Event
    September 29, 2005
    Report Date
    September 29, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A AQ2003V 3 PIECE SILICONE LENS. THE LENS HAPTIC TORE DURING INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND REQUIRED A SUTURE TO CLOSE THE WOUND. THE REPORTER STATED THAT THE LENS WAS LOADED INTO THE FIRST AQ CARTRIDGE-FP. LOT NUMBER 1204617 TOO SOON, THE LENS WAS REMOVED AND WAS LOADED INTO ANOTHER AQ CARTRIDGE FP, LOT NUMBER 1203802.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention