BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1923771 · Received December 1, 2010

    Report

    Report Number
    2023826-2010-01222
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 4, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVAL METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND OPTIC AND HAPTICS ARE TORN. HALF OF THE LENS IS TORN OFF AND MISSING. LENS WAS RETURNED IN VIAL AND IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON USED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. THE SURGEON WAS ADVANCING THE LENS IN THE INJECTOR, THEN HE NOTICED, THE LENS HAD TORN. LENS WAS NOT INSERTED INTO THE EYE. THERE WAS NO PT CONTACT. BACKUP LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR CARTRIDGE: MODEL -NANOPOINT, LOT NUMBER UNK| INJECTOR: MODEL - NANOPOINT, LOT NUMBER UNK