BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2983623 · Received February 28, 2013

    Report

    Report Number
    2023826-2013-00170
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 23, 2011
    Report Date
    February 7, 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).

    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 NO VISIBLE DAMAGE TO THE LENS. 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 - PSCO IS MOST PROBABLY RELATED TO THE HIGH MYOPIA. ICL-INDUCED OPACITIES ARE TYPICALLY ASCO (ANTERIOR SUB-CAPSULAR). HIGH MYOPIA IS ASSOCIATED WITH AN EARLIER ONSET OF NUCLEAR AND PSCO OPACITIES. 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2005. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO A POSTERIOR SUBCAPSULAR OPACITY. THE CATARACT WAS OBSERVED ON (B)(6) 2011. THE CATARACT WAS REMOVED AND AN IOL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86159 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK