BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2152623 · Received June 22, 2011

    Report

    Report Number
    2023826-2011-00553
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW. RESULTS: AFTER REVIEWING THE COMPLAINT REPORT FORM, PRODUCT EVALUATION AND THE DEVICE HISTORY RECORD, THERE IS NO EVIDENCE THAT SHOWS WHAT THE ROOT CAUSE OF THIS COMPLAINT IS. THE LENS WAS MOST LIKELY DAMAGED UPON REMOVAL FROM THE VIAL. ANY SHARP INSTRUMENT USED BY THE FACILITY CAN CAUSE THIS TYPE OF DAMAGE TO THE LENS IF THE PRODUCT IS HANDLED INCORRECTLY. CONCLUSION: UNABLE TO CONFIRM. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION AND DEVICE HISTORY REVIEW, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THERE WAS A LIGHT SCRATCH AND A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE MICL13.2 IMPLANTABLE COLLAMER LENS WAS OPENED AND THERE WAS A LINE GOING ACROSS THE LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH FORM 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. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR