BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CAHMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 3030844 · Received March 28, 2013

    Report

    Report Number
    2023826-2013-00249
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    July 18, 2012
    Report Date
    March 18, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) -BREAK, HAPTIC; BREAK, OPTIC. EVALUATION RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC HAS TEARS. LOOP HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. CONCLUSIONS: 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 A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS WAS USED. THE LENS HAPTIC BROKE. NO PT CONTACT. NO FURTHER INFORMATION AVAILABLE. CAUSE OF BROKEN HAPTIC IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127779 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CAHMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INJECTOR MODEL - UNK - LOT NUMBER - UNK| CARTRIDGE MODEL - UNK - LOT NUMBER - UNK