BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2200425 · Received August 11, 2011

    Report

    Report Number
    2023826-2011-00708
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: LENS WORK ORDER SEARCH 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 ONE HAPTIC TORN. THE LENS WAS RETURNED DRY AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, TEARS, RIPS, HOLES IN DEVICE, DEVICE MATERIAL. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS BUT THE LENS TORE. THE LENS WAS NOT IMPLANTED. ANOTHER SAME MODEL LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL AND LOT NUMBER UNKNOWN| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE: MODEL AND LOT NUMBER UNKNOWN