BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1883949 · Received October 21, 2010

    Report

    Report Number
    2023826-2010-01063
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 22, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: METHOD (OTHER): WORK ORDER SEARCH. RESULTS (OTHER) - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS SPLIT AND A PIECE OF THE HAPTIC/OPTIC WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. A PARENT/CHILD WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAPTIC TORE AS THE SURGEON INSERTED A CC4204A COLLAMER PLATE LENS. THE LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED WITHOUT ANY PT 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 69 YR NANOPOINT INJECTOR, LOT # UNK| NANOPOINT CARTRIDGE, LOT # UNK