BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3160206 · Received June 10, 2013

    Report

    Report Number
    2023826-2013-00481
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CC4204A SINGLE PIECE COLLAMER LENS RIPPED AS IT WAS PLACED IN THE EYE. THE LENS WAS CUT, REMOVED FROM THE EYE AND DISCARDED WITHOUT ANY PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE EVENT WAS THE RESULT OF A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260221 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NANOPOINT INJECTION SYSTEM, LOT NUMBER UNKNOWN