BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3971883 · Received July 31, 2014

    Report

    Report Number
    2023826-2014-00571
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    March 4, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED DRY AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON 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. MEDICAL REVIEW - GLARES AND HALOS MAY BE NOTED BY PATIENTS EVEN IF THEY NEVER HAD ANY OCULAR SURGERY. THIS IS COMMONLY DUE TO ABERRATIONS OR IRREGULARITIES IN THE CORNEA. IT MAY BE NOTED MORE AT LOW LIGHT CONDITIONS WHEN THE PUPIL IS DILATED. IN ICL SURGERY, THE CENTRAL AND MID PERIPHERAL CORNEA IS NOT TOUCHED, THEREFORE PATIENTS WHO HAVE GLARES AND HALOS BEFORE THE SURGERY, WILL COMMONLY RETAIN THESE SYMPTOMS BUT LITTLE OR NO INCREASE IN SEVERITY SHOULD BE EXPERIENCED SINCE THE CENTRAL AND MID PERIPHERAL REGION REMAINS UNABLATED AND ONLY A CORNEAL INCISION WITH A MAXIMUM LENGTH OF 3.2MM AT THE TEMPORAL PERIPHERAL REGION IS MADE. GLARE AND HALOS MAY ALSO BE PERCEIVED MORE DUE TO THE INCREASED CLARITY OF VISION AFTER ICL SURGERY OR IF THE PATIENT HAS RETAINED ASTIGMATISM. ANOTHER FACTOR COULD ALSO BE THE EFFECTIVE OPTICAL CORNEAL ZONES (EOCZ) OF THE ICLS, WHICH HAVE A MAXIMUM DIAMETER OF 6.17 TO 7.30 MM DEPENDING ON THE ICL POWERS. THIS IS A DESIGN LIMITATION WHICH MAY CREATE SIMILAR SYMPTOMS OF GLARE AND HALOS DUE TO THE INTERFACE OF THE OPTICAL ZONE AND THE PATIENT'S OPTICAL FIELD OF VISION, WHICH MAY BE NOTED WHEN THE PUPIL SIZE IS GREATER THAN THE EOCZ. THE 0.36MM HOLE AT THE CENTER OF THE ICL HAS BEEN COMPARED TO THE ICL WITHOUT A HOLE WHICH SHOWED THAT MODULATION-TRANSFER FUNCTIONS (MTF) ARE SMALL AND CLINICALLY NEGLIGIBLE. GLARES AND HALOS ARE COMMONLY TEMPORARY, LASTING 1-6 MONTHS, BUT MAY ON VERY RARE OCCASIONS BECOME PERMANENT. THIS CONDITION IS CONSIDERED TRIVIAL AND TEMPORARY AND SHOULD NOT BE MDR REPORTABLE UNLESS MEDICAL OR SURGICAL INTERVENTION WAS DONE TO ELIMINATE SEVERE SYMPTOMS. CONCLUSIONS: 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).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). EVALUATION CODES: METHOD -(OTHER): WORK ORDER SEARCH RESULTS - (OTHER): 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 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2013. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO PATIENT EXPERIENCING GLARE/HALOS AND BLURRED VISION. THE LENS WAS NOT EXCHANGED FOR ANOTHER ICL. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446647 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK