BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1984304 · Received February 10, 2011

    Report

    Report Number
    2023826-2011-00090
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    August 26, 2010
    Report Date
    January 21, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW - REVIEW OF THE FILE INDICATES THAT THE LENS WAS NOT IMPLANTED IN ACCORDANCE WITH THE DFU REQUIREMENTS (E.G. PATIENT AGE (B)(6), ACD BELOW 2.8MM FOR ICL/TICL AND BELOW 3.0MM FOR VICL/VTICL, KERATOCONUS, PREGNANT OR NURSING PATIENTS, PATIENTS WITH LOW/ABNORMAL CORNEAL ENDOTHELIAL CELL DENSITY, FUCH'S DYSTROPHY OR OTHER CORNEAL PATHOLOGY, PATIENTS WHO ARE AMBLYOPIC OR BLIND IN THE FELLOW EYE). OFF-LABEL USE OF THE DEVICE, NO CLINICAL DATA CAN SUPPORT THE COMPLAINT EVENT(S) OR THE EFFECT(S) ON THE EFFICACY AND SAFETY OF THE DEVICE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A PROBABLE CAUSE OF THE EVENT IS THE OFF-LABEL USE OF THE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM (B)(4) IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2007. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO AN ANTERIOR SUBCAPSULAR OPACITY HAD DEVELOPED. THE OPACITY WAS OBSERVED ON (B)(6) 2010. THE CATARACT WAS REMOVED AND AN IOL WAS IMPLANTED. THE PATIENT'S POST-OP BCVA WAS 20/28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY ICM120V4

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention FOAM TIP PLUNGER MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE MODEL AND LOT NUMBER UNKNOWN| INJECTOR MODEL AND LOT NUMBER UNKNOWN