BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2142230 · Received May 26, 2011

    Report

    Report Number
    2023826-2011-00457
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 5, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED IN LIQUID AND THERE WERE TEARS. A HAPTIC PLATE WAS TORN OFF. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A CC4204A COLLAMER PLATE LENS AND THE LENS TORE UPON INSERTION. THE LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED W/O ANY PATIENT INJURY.

    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 CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NANOPOINT CARTRIDGE: LOT NUMBER UNKNOWN| NANOPOINT INJECTOR: LOT NUMBER UNKNOWN