BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 5041164 · Received August 29, 2015

    Report

    Report Number
    2023826-2015-01101
    Event Type
    Injury
    Date Received
    August 29, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REFRACTIVE SURPRISE WAS REPORTED. HEALTH PROFESSIONAL AND DISTRIBUTOR ARE NOT THE REPORT SOURCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (EVALUATION METHOD) - LENS WORK ORDER SEARCH. RESULTS: (EVALUATION RESULTS) - A LENS WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4): LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICH13.2 IMPLANTABLE COLLAMER LENS, +1.0/+5.0/025 DIOPTER IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2015. THE LENS ROTATED AFTER SURGERY. THE SURGEON DECIDED TO ADJUST THE AXIS AND REPOSITIONED THE LENS ON (B)(6) 2015. DURING FOLLOW-UP VISIT, IT WAS NOTED THE LENS ROTATED AGAIN. THE LENS REMAINS IMPLANTED. A SUPPLEMENTAL WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573701 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG VTICH13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention