BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3013544 · Received March 20, 2013

    Report

    Report Number
    2023826-2013-00222
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE VISUAL INSPECTION OF THE RETURNED LENS SHOWED HALF THE LENS WAS TORN OFF AND MISSING AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE AQ2015A SILICONE THREE PIECE LENS TORE AS IT WAS INSERTED IN THE EYE. THE LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115855 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 AQ CARTRIDGE-FP, LOT NUMBER UNKNOWN| MSI-PM INJECTOR MODEL, LOT NUMBER UNKNOWN