BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1822050 · Received August 20, 2010

    Report

    Report Number
    2023826-2010-00826
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 30, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: CARTRIDGE LOT NUMBER SEARCH, LENS WORK ORDER SEARCH. METHOD: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS STUCK IN THE RETURNED CARTRIDGE. THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. THERE WAS EVIDENCE OF DARK SURGICAL RESIDUE INSIDE THE CARTRIDGE. A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, LOT NUMBER SEARCH, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A -16.0 DIOPTER 12.6 MM MICL12.6 IMPLANTABLE COLLAMER LENS, BUT THE LENS FELT TIGHT IN THE CARTRIDGE AND WOULD NOT ADVANCE. THE CARTRIDGE WAS IN THE PT'S EYE, BUT THERE WAS NO CONTACT WITH THE LENS. THERE WAS NO PT INJURY. THE BACKUP ICL WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE SURGEON FELT THE EVENT WAS DUE TO THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL CO. SFC-45 FP 1231943

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR LENS: MODEL MICL12.6, (B)(4)| FOAM TIP PLUNGER: MODEL FOAM TIP PLUNGER, LOT# UNK| INJECTOR: MODEL MSI-PF, LOT # UNK