BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1870332 · Received October 5, 2010

    Report

    Report Number
    2023826-2010-01017
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), LENS WOULD NOT SEAT PROPERLY IN THE EYE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON INSERTED A CQ2015A SILICONE PLATE LENS AND COULD NOT GET IT SEATED PROPERLY IN THE EYE. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED, THE INCIDENT IS THE RESULT OF A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK