BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2133606 · Received June 16, 2011

    Report

    Report Number
    2023826-2011-00532
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED DRY AND THERE WAS NO VISIBLE DAMAGE OBSERVED. THE LENS DIMENSIONS WERE RE-MEASURED AND FOUND TO BE WITHIN THE ORIGINAL DESIGN SPECIFICATIONS. A WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION AND LENS INSPECTION, IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THE EVENT WAS A USER OR TECH ERROR (LENS WAS TOO LONG OUTSIDE THE VIAL OR WAS TOO LONG IN CARTRIDGE). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN (B)(4) 11.5MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND THE LENS WOULD NOT EXPANDED IN THE ANTERIOR CHAMBER. THE LENS WAS REMOVED IMMEDIATELY AND REPLACED WITH ANOTHER ICL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR