BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3194254 · Received June 27, 2013

    Report

    Report Number
    2023826-2013-00532
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 13, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - IRITIS. DEVICE EVALUATED BY MANUFACTURER? NO - LENS REMAINS IMPLANTED. 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). LENS REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REPORTEDLY VISIAN ICL(13.2) WAS EXPLANTED/EXCHANGED FOR A SHORTER LENS (12.1) , EIGHT MONTHS POSTOPERATIVELY, TO ADDRESS RECURRENT IRITIS CAUSED BY EXCESSIVE VAULT . UBM PREOPERATIVE SULCUS TO SULCUS MEASUREMENT WAS PROVIDED (11.7MM) DFU INSTRUCTS PHYSICIANS HOW TO PROPERLY CHOOSE THE LENS: "VISIAN ICL LENGTH DETERMINATION: DURING THE U.S. MULTI-CENTER CLINICAL STUDY, SIZING OF THE VISIAN ICL MYOPIC LENSES (12.1 TO 13.7MM) WAS DETERMINED BY THE HORIZONTAL WHITE-TO-WHITE AND THE ANTERIOR CHAMBER DEPTH (ACD) MEASUREMENTS). W-TO-W MEASUREMENTS: ARE AN INDIRECT MEASUREMENT AND POORLY CORRELATE WITH SULCUS MEASUREMENTS. NEWER ADVANCEMENTS IN THE DIRECT MEASUREMENT OF THE CILIARY SULCUS SUCH AS ULTRASONIC BIOMICROSCOPY (UBM) SHOULD BE CONSIDERED ALTERNATIVE METHODS FOR THE DETERMINATION OF THE DESIRED VISIAN ICL LENGTH OVERALL DIAMETER. AT PRESENT THERE IS NO LARGE SERIES DEMONSTRATING THE EFFECTIVENESS OF UBM IN VISIAN ICL SIZING". GIVEN THE INFORMATION THAT THE REPLACEMENT WITH A SHORTER LENS RESOLVED THE ISSUE THE MOST LIKELY CAUSE OF THE EVENT WAS PROCEDURE RELATED FACTOR( CALCULATION ERROR) COMBINED WITH PATIENT FACTOR ( ANATOMY). 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 PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS IN HER RIGHT EYE (OD) ON (B)(6) 2012. PATIENT HAS REPORTED SHE HAS IRITIS. THE ICL REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE FACILITY INDICATED AT THE LAST VISIT ON (B)(6) 2014, THE PATIENT'S VA WAS 20/20, THE PROGNOSIS WAS GOOD AND THE PROBLEM WAS RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER STATED THE LENS WAS EXPLANTED ON (B)(6) 2013 DUE TO EXCESSIVE VAULTING AND RECURRING IRITIS. THE LENS WAS REMOVED THROUGH THE ORIGINAL INCISION WITH NO PATIENT INJURY AND A SHORTER LENS WAS IMPLANTED. THE REPORTER STATED THE PATIENT DID NOT HAVE ANY RELATED COMPLICATIONS TO THE EXCESSIVE VAULTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294748 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK