BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2002128 · Received February 2, 2011

    Report

    Report Number
    2023826-2011-00086
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 5, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (NO PRODUCT MALFUNCTION). RESULTS: (OTHER) - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF THE LENS OPTIC AND ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS WITHIN THE SAME SURGERY DUE TO THE SURGEON CHANGING HIS MIND FOR ANOTHER MODEL LENS. THE REPORTER STATED THE PATIENT HAD CORNEAL DISEASE AND THE CORNEA WAS EXTREMELY CLOUDY. THE LENS WAS REMOVED IN PIECES WITH NO PATIENT INJURY. THE REPORTER STATED THE EVENT WAS DUE TO THE PATIENT'S CONDITION AND WAS NOT LENS RELATED.

    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 LOT NUMBER UNK| CARTRIDGE: MODEL CQ CARTRIDGE-FP| INJECTOR: MODEL AND LOT NUMBER UNK| LOT NUMBER: