BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 873415 · Received June 29, 2007

    Report

    Report Number
    2023826-2007-01100
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    May 31, 2007
    Report Date
    June 4, 2007
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LPN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS NO VISIBLE DAMAGE TO THE LENS. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. A WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THERE WAS ONE SIMILAR COMPLAINT FOUND. CONCLUSION: AT THE CONCLUSION OF THE ORIGINAL INVESTIGATION OPENED FOR THE ISSUE OF ICL VAULTING (BOTH INADEQUATE AND EXCESSIVE), IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR BOTH INADEQUATE AND EXCESSIVE VAULT IS DIFFICULTY IN CLINICAL SIZING. IN NO CASE HAS A RETURNED LENS EXHIBITED A LENGTH MEASUREMENT OUTSIDE THE EXPECTED RANGE ACCORDING TO THE LABELED LENGTH. PRE-OPERATIVE MEASUREMENT TECHNOLOGY AVAILABLE TO CLINICIANS IN THE PAST DID NOT PROVIDE A DIRECT MEASUREMENT OF THE SULCUS, TO WHICH THE ICL SHOULD BE SIZED. THE CURRENT PRACTICE IN SELECTING AN APPROPRIATE ICL FOR A PT IS TO MEASURE WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH AND, THROUGH CORRELATIVE ALGORITHM PREDICT THE LENGTH OF THE ICL THAT WILL BRIDGE THE SULCUS. THIS METHOD OF SIZING BASED UPON WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH MEASUREMENTS WAS USED IN THE FDA CLINICAL TRIAL, AND IS RECOMMENDED IN THE CURRENT LABELING OF THE ICL. IF THE PREDICTED LENGTH IS TOO SHORT, THE RESULT MAY BE AN INADEQUATE VAULT. IF PREDICTED LENGTH IS TOO LONG, THE RESULT MAY BE AN EXCESSIVE VAULT. EVALUATION NEWLY AVAILABLE, ALTERNATE MEASURING DEVICES IS ONGOING.

    Description of Event or Problem · 1

    THE REPORTED STATED THAT THE SURGEON INSERTED A VISION ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 12.1MM IN 2007, AND DUE TO PT EXPERIENCING DOUBLE VISION, EXPLANTED AND REPLACED IT WITH A LARGER MICL ABOUT THREE WEEKS LATER. THE REPORTER STATED THAT IT WAS DUE TO AN INADEQUATE VAULT, AND THE SURGEON HAD MIS-MEASURED THE PT'S SULCUS, AND PUT IN TOO SMALL OF A LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL MICL 12.1 NA

    Patients

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