BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4102208 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00718
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS STUCK IN THE CARTRIDGE TRAY AND WAS UNABLE TO EVALUATE THE LENS. THE LENS WAS RETURNED DRY. MEDICAL REVIEW - REPORTEDLY ICL WAS EXPLANTED/EXCHANGED FOR A SHORTER LENGTH ICL, TWO WEEKS POSTOPERATIVELY, TO ADDRESS EXCESSIVE VAULTING AND SUBSEQUENT IRITIS THAT WAS MEDICALLY TREATED. UPON LENS EXCHANGE PATIENT STATUS IMPROVED AND VA WAS 20/20. IT SHOULD BE NOTED THAT LITERATURE REPORTS THAT EXCESSIVE ICL VAULT IS USUALLY DUE TO AN OVERESTIMATION OF ICL SIZE. GIVEN THE INFORMATION THAT SHORTER LENS WAS USED AS A REPLACEMENT IT IS VERY LIKELY THAT THE PROCEDURE RELATED FACTOR (MISCALCULATION) HAVE CAUSED THE REPORTED EVENT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A LIKELY CAUSE OF THE EVENT WAS PROCEDURE RELATED FACTOR (MISCALCULATION). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, 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 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2014. AT ONE DAY POST-OP, THE VAULT WAS GOOD, WITH SOME BLURRINESS. OVER THE NEXT TWO WEEK PERIOD, THE ICL HAD EXCESSIVE VAULTING. THE PATIENT EXPERIENCED IRITIS, GRAINY VISION, AND HAD A LIGHT HEADACHE. THE PATIENT WAS PRESCRIBED EYE DROPS. THE LENS WAS EXPLANTED ON (B)(6) 2014 AND WAS EXCHANGED FOR A SHORTER LENS. A NEW INCISION WAS OPENED AND SUTURES WERE NOT REQUIRED. AT ONE WEEK POST-OP, PRESSURE WAS GOOD, VA WAS 20/20 IN BOTH EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584365 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention INJECTOR MODEL MSI-PF - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK