BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6152132 · Received December 7, 2016

    Report

    Report Number
    2023826-2016-01707
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    March 31, 2016
    Report Date
    November 8, 2016
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNK. PMA 510(K): THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. PATIENT CODES: \- SIGNIFICAT REDUCTION OF ENDOTHELIAL CELL COUNTING OR SIGNIFICANT ENDOTHELIAL CELL LOSS, SECONDARY SURGICAL INTERVENTION, LENS EXPLANTED. (B)(4). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    PMA 510(K): THIS PRODUCT IS NOT MARKETED IN THE U.S. WORK ORDER SEARCH: NO SIMILAR COMPLAINTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED DRY IN THE LENS CONTAINER, BUT THERE WAS CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND OPTIC SPLIT, HAPTIC BROKEN AND DEFORMED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.5 MM ICM125V4 IMPLANTABLE COLLAMER LENS, -16.50 DIOPTER IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2013. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL COUNTING OR SIGNIFICANT ENDOTHELIAL CELL LOSS. THE PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY WAS 20/200. THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804311 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM125V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention