BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3841601 · Received May 30, 2014

    Report

    Report Number
    2023826-2014-00394
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER®ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). EVALUATION CODES: RESULTS (OTHER) VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A HAPTIC HAD TORE OFF FROM THE OPTIC AND WAS MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE TRAINING A NEW SURGERY TECH WHO WAS HAVING DIFFICULTY POSITIONING THE CC4204A COLLAMER SINGLE PIECE LENS IN THE INJECTION SYSTEM. CONSEQUENTLY, THE FOAM TIP PLUNGER OVERRODE AND TORE THE LENS AS THE SURGEON WAS INSERTING IT. THE LENS WAS REMOVED AND REPLACED WITHOUT ANY INJURY TO THE PATIENT. THE REPORTER STATED EVENT WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317946 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR INDIGO-P FTP MODEL, LOT NUMBER UNKNOWN| INDIGO-P INJECTOR MODEL, LOT NUMBER UNKNOWN| SFC-25FP CARTRIDGE MODEL, LOT NUMBER UNKNOWN