BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2970544 · Received February 20, 2013

    Report

    Report Number
    2023826-2013-00142
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 29, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. TORN MATERIAL. DEVICE EVALUATED BY MANUFACTURER? NO. LENS WAS NOT RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF. A PIECE OF THE LENS OPTIC AND THE OTHER HAPTIC WERE TORN OFF. THE LENS WAS RETURNED DRY. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO USER ERROR OR POOR CARTRIDGE LUBRICITY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A CC4204BF COLLAMER SINGLE PIECE LENS AND THE LENS HAPTIC WAS DAMAGED. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75018 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INJECTION SYSTEM MODEL - NANOPOINT - LOT # UNK