BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6074358 · Received November 2, 2016

    Report

    Report Number
    2023826-2016-00927
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    November 4, 2015
    Report Date
    June 9, 2016
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WAS RETURNED IN LIQUID IN A LENS CASE/VIAL WITH CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS AND FOREIGN MATERIAL ON LENS SURFACE (DISCOLORED). FUNCTIONAL AND DIMENSIONAL INSPECTIONS FOUND THE LENS TO BE WITHIN SPECIFICATIONS. CLAIM #: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN (B)(4) BUT NOT MARKETED IN THE U.S. (B)(4). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED: THE REPORTER STATED THAT THE LENS WAS EXPLANTED ON (B)(6) 2016. (B)(4). AS PER DFU FOR THIS LENS MODEL, IMPLANTATION OF THIS LENS IN AN INDIVIDUAL WITH KERATOCONUS IS CONTRAINDICATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICH12.6 IMPLANTABLE COLLAMER LENS, +5.50/+3.0/060 DIOPTER, IN THE PATIENT'S LEFT EYE ON (B)(6) 2015. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723845 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG VTICH12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention