BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4111147 · Received September 23, 2014

    Report

    Report Number
    2023826-2014-00755
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 4, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO - 81 (OTHER): LENS WAS DISCARDED BY THE FACILITY. EVALUATION CODES: 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). LENS WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - REPORTEDLY ICL WAS EXPLANTED TWO MONTHS POSTOPERATIVELY, BY A DIFFERENT SURGEON, TO ADDRESS ELEVATED IOP AND SUBSEQUENT SUBJECTIVE SYMPTOMS (BLURRINESS, PAIN, HEADACHE). BEFORE EXPLANTATION THE PATIENT WAS PRESCRIBED GLAUCOMA MEDICATIONS. NO REPORTED LOSS OF BCVA PRIOR TO THE LENS EXPLANTATION. NO ICL WAS IMPLANTED AS A REPLACEMENT. THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE THE DEVICE CAUSALITY SINCE THE PATIENT RELATED FACTORS (PIGMENT DISPERSION SYNDROME, SHALLOW ANTERIOR CHAMBER) AND/OR PROCEDURE RELATED FACTORS (NON-PATENT IRIDOTOMIES, MISCALCULATION) COULD HAVE CAUSED THE REPORTED ISSUE. THE MOST LIKELY DIAGNOSIS IN THIS CASE IS PUPILLARY BLOCK. THIS CONDITION IS THE MOST COMMON CAUSE OF HIGH IOP SEVERAL DAYS AFTER THE VISIAN ICL'S IMPLANTATION AND RESULTS FROM NONFUNCTIONING PIS. THE ONLY WAY TO VERIFY PATENCY IS TO VISUALIZE THE STRUCTURES POSTERIOR TO THE PI'S OPENING, LIKE THE EDGE OF THE ICL OR ANTERIOR CAPSULE. BASED ON DATA FOR THE ICL'S FDA PREMARKET APPROVAL, MOST SURGEONS PERFORM ND: YAG PIS, AND APPROXIMATELY 5% OF THEM DO NOT FUNCTION, WHICH LEADS TO INCREASED POSTOPERATIVE IOP. DILATING THE IRIS CAN OFTEN TEMPORARILY BREAK THE PUPILLARY BLOCK. THE DEFINITIVE TREATMENT IS TO ENLARGE THE PI(S) AND/OR CREATE ADDITIONAL PIS, EITHER SURGICALLY OR WITH THE ND: YAG LASER. AN OVERSIZED ICL (EXCESSIVE VAULT) INCREASES THE RISK OF PUPILLARY BLOCK IN EYES WITH NONFUNCTIONING PIS, AND SUCH EYES GENERALLY WILL NOT RESPOND TO DILATION TO BREAK THE BLOCK SO EXPLANTATION OF ICL IS NECESSARY. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, 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 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2014. THE REPORTER INDICATED AT THE SAME DAY POST-OP CHECK-UP, CELLS/PIGMENT WAS NOTED IN THE ANTERIOR CHAMBER. AT THE ONE DAY POST-OP VISIT, THE ANTERIOR CHAMBER WAS CLEAR. OVER THE NEXT EIGHT WEEKS, THE PATIENT HAD INTRAOCULAR PRESSURE PROBLEMS, WHICH WAS BEING CONTROLLED WITH MEDICATION. THE PATIENT EXPERIENCED PAIN/SCRATCHINESS, BLURRINESS, CELL AND FLARE. THE EYE WAS RED AND SWOLLEN. THE SURGEON DECIDED TO EXPLANT THE LENS ON (B)(6) 2014. THE LENS WAS NOT EXCHANGED FOR ANOTHER ICL. AT THE POST-OP VISIT ON (B)(6) 2014, THE VA WAS 20/2500 AND THE PATIENT COMPLAINED OF HEADACHE. THE LENS WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592135 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK