BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2810037 · Received October 23, 2012

    Report

    Report Number
    2023826-2012-00823
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    November 9, 2011
    Report Date
    September 24, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULT - A LENS WORK ORDER SEARCH WAS PERFORMED AND TWO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - ANTERIOR SUBCAPSULAR CATARACT IS A LABELED COMPLICATION IN THE IMPLANTATION OF AN ICL. CATARACT EXTRACTION MAY BE NECESSARY IF VISION IS COMPROMISED, TO PRECLUDE INCREASE IN SEVERITY OF THE CONDITION. IF THE CONDITION IS NON-PROGRESSIVE, THE SURGEON MAY OPT TO LEAVE THE ICL, ESPECIALLY WHEN THERE IS NO DECREASE IN VISUAL ACUITY. IN THE US FDA CLINICAL TRIALS, APPROX 6% TO 7% OF EYES DEVELOPED ANTERIOR SUBCAPSULAR OPACITIES AT 7 YEARS FOLLOWING ICL IMPLANTATION, BUT ONLY 1% - 2% PROGRESSED TO CLINICALLY SIGNIFICANT CATARACT DURING THE SAME PERIOD. CATARACT EXTRACTION WAS PERFORMED IN THIS CASE WHICH RESOLVED THE PROBLEM. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE ON (B)(6) 2007. PRK WAS PERFORMED ON (B)(6) 2007. ANTERIOR CATARACT WAS OBSERVED ON (B)(6) 2011. ICL WAS EXPLANTED AND CATARACT SURGERY WAS PERFORMED, AN IOL WAS IMPLANTED ON (B)(6) 2011. SEE MFR #2023826-2012-00824 FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention CARTRIDGE: MODEL & LOT # UNK| INJECTOR: MODEL & LOT # UNK| FOAM TIP PLUNGER: MODEL & LOT # UNK