BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1962850 · Received January 12, 2011

    Report

    Report Number
    2023826-2011-00045
    Event Type
    Injury
    Date Received
    January 12, 2011
    Report Date
    December 17, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (VISUAL INSPECTION OF THE LENS FOUND NO ROUGH/SHARP EDGES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) (SECONDARY SURGERY). (B)(4). EVAL, METHOD: (OTHER): LENS WORK ORDER SEARCH. RESULTS: (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF BOTH HAPTICS AND THE LENS OPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - GLARE AT NIGHT, PAIN. EVALUATION METHOD: MEDICAL REVIEW. RESULTS: PER 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 U.S. FDA CLINICAL TRIALS, APPROXIMATELY 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, 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

    ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY: THE REPORTER INDICATED UPON EXPLANT OF THE ICL, THE CATARACT WAS REMOVED AND A DIFFERENT MODEL LENS WAS IMPLANTED. THE REPORTER INDICATED THE PATIENT EXPERIENCED GLARE AT NIGHT AND PAIN. THE PATIENT'S CURRENT BCVA IS 20/25.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE (OS) ON (B)(6) 2007. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO THE PATIENT HAVING DEVELOPED A CATARACT. ADD'L INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL 12.1 NA

    Patients

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