BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1903101 · Received November 15, 2010

    Report

    Report Number
    2023826-2010-01144
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND OPTIC TORN. PIECE OF OPTIC AND HAPTIC TORN OFF. LENS WAS RETURNED IN VIAL AND IN LIQUID. CONCLUSIONS- A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVALUATION OF TEST RESULTS. ADDITIONALLY, THE INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. LENS WAS REMOVED DUE TO TORN HAPTIC. THERE WAS NO PT INJURY.

    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 COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL - MSI-PM, LOT NUMBER - UNK| VISCOELASTIC-STAARVISC II, LOT NUMBER - UNK| CARTRIDGE MODEL-CQ CARTRIDGE-FP, LOT NUMBER-UNK