BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 908128 · Received September 6, 2007

    Report

    Report Number
    2023826-2007-01526
    Event Type
    Malfunction
    Date Received
    September 6, 2007
    Report Date
    August 9, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PORTION OF THE LENS OPTIC AND ONE HAPTIC TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON WAS INSERTING A THREE PIECE ASPHERIC COLLAMER LENS, MODEL NUMBER CQ2015A AND THE TRAILING HAPTIC TORE. THE SURGEON REMOVED THE LENS WITH NO PATIENT INJURY AND WITHOUT ENLARGING THE INCISION. ANOTHER LENS WAS INSERTED AND SUTURES WERE NOT REQUIRED. THIS IS ONE OF TWO INCIDENTS THAT OCCURRED TO THIS SAME PATIENT. SEE MANUFACTURER REPORT NUMBER 203826-2007-01525 FOR THE OTHER INCIDENT.

    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 YR VISCOELASTIC TYPE: STAARVISC II LOT NUMBER UNK| INJECTOR MODEL - LOT NUMBER UNK| CARTRIDGE MODEL - LOT NUMBER UNK