BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3191653 · Received June 26, 2013

    Report

    Report Number
    2023826-2013-00514
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    November 17, 2012
    Report Date
    May 29, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INTRAOCULAR PRESSURE RISE; PUPILLARY BLOCK. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED DRY. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. MEDICAL REVIEW - PUPIL BLOCK WITH ELEVATED IOP AFTER ICL IMPLANTATION MAY OCCUR DUE TO: NON PATENT/FUNCTIONING IRIDECTOMIES (TOO SMALL, TOO PERIPHERAL AND/OR NOT FULLY PERMEABLE, BLOCKED BY VISCO), REMAINING VISCOELASTIC IN THE POSTERIOR CHAMBER, OVERSIZED ICL WITH ANGLE CLOSURE, TOO NARROW ANGLES/CROWDED AC DUE TO SMALL EYE ANATOMY PREOPERATIVELY, UNEXPECTED ABNORMAL ANATOMY OR TISSUE ABNORMALITIES (PRESENCE OF IRIS/CILIARY BODY CYSTS), HYPERTENSIVE RESPONSE TO STEROIDS, ETC. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. CLAIM # 705409

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO PUPIL BLOCK, WITH ELEVATED IOP. THE PATIENT'S BCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291632 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK