BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2011128 · Received March 8, 2011

    Report

    Report Number
    2023826-2011-00147
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 8, 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

    (B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY, UNREACTIVE PUPIL (FIXED). (B)(4) - EXPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, MEDICAL REVIEW RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED DRY. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. MEDICAL REVIEW - DAMAGE TO THE PUPIL IS USUALLY DUE TO VASCULAR DAMAGE AS A RESULT OF TRAUMA/INFLAMMATION/ISCHEMIA. SOME PATIENTS MAY HAVE IRIS VASCULATURE ABNORMALITIES AND COULD DEVELOP ISCHEMIA IN THE EVENT OF TRANSIENT/PERSISTENT HIGH IOP, ALTHOUGH ETIOLOGY OF THE NON-FUNCTIONAL PUPIL IS STILL NOT CLEAR. (URRET ZAVALIA'S SYNDROME). CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION 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 INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO AN UNREACTIVE PUPIL (FIXED) AND URRETS-ZAVALIA SYNDROME. THE SURGEON PERFORMED PHACO WITHOUT CATARACT TO SOLVE THE ANISOMETROPIA AND AN IOL WAS IMPLANTED. THE PATIENT'S POST-OP BCVA WAS 20/22.

    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 47 YR Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK