BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 6545668 · Received May 4, 2017

    Report

    Report Number
    2023826-2017-00764
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 5, 2017
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS: LENS DIOPTER -17.00/250/125; CORRECTED: LENS DIOPTER -17.00/2.5/125. DEVICE EVALUATION, PREVIOUS: STATED THERE WAS CLEAR SURGICAL RESIDUE/DEBRIS ON THE PRODUCT. CORRECTED: NO CLEAR RESIDUE/DEBRIS WAS FOUND ON THE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    PREVIOUS: LENS REMAINS IMPLANTED. ON (B)(6) 2017, THE LENS WAS EXCHANGED FOR A SAME SIZE, SIMILAR DIOPTER LENS. UCVA IS 20/20, VAULT IS ~500UM. THE PATIENT IS HAPPY, PROBLEM IS RESOLVED. METHOD CODE, PREVIOUS:(NO TESTING METHODS PERFORMED). UPDATED: (DEVICE FROM SAME LOT EVALUATED). RESULT CODE, PREVIOUS: (OPERATIONAL PROBLEM). UPDATED: (NO FAILURE DETECTED). WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPES REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    PREVIOUS: LENS REMAINS IMPLANTED. ON (B)(6) 2017, THE LENS WAS EXCHANGED FOR A SAME SIZE, SIMILAR DIOPTER LENS. UCVA IS 20/20, VAULT IS ~500UM. THE PATIENT IS HAPPY, PROBLEM IS RESOLVED. METHOD CODE, PREVIOUS:(NO TESTING METHODS PERFORMED). UPDATED: (DEVICE FROM SAME LOT EVALUATED). RESULT CODE, PREVIOUS: (OPERATIONAL PROBLEM). UPDATED: (NO FAILURE DETECTED). WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPES REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    LENS WAS RETURNED IN LIQUID IN A LENS CONTAINER. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS AND CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. DIMENSIONAL INSPECTION FOUND LENS IS WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6, DIOPTER -17.00/250/125 IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE PATIENT BEGAN TO EXPERIENCE REFRACTIVE SURPRISE. AS OF THE DATE OF MDR REPORTING THE LENS REMAINS IMPLANTED, HOWEVER A LENS EXCHANGE IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325526 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R