BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 834485 · Received March 29, 2007

    Report

    Report Number
    2023826-2007-00543
    Event Type
    Other
    Date Received
    March 29, 2007
    Date of Event
    February 24, 2007
    Report Date
    March 1, 2007
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: 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 ONE SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS: 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 EXCESSIVE VAULT. EVALUATION OF NEWLY AVAILABLE, ALTERNATE MEASURING DEVICES IS ONGOING.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 13.2 MM INTO PT'S EYE AND REALIZED THAT IT WAS TOO LONG FOR THE PT; SO, THE SURGEON REMOVED IT WITHOUT ENLARGING INCISION AND REPLACED IT WITH A SHORTER LENS. THE REPORTER STATED THAT THE LENS WAS NOT MISLABELED THAT IT WAS DUE TO A MIS-CALCULATION OF THE PT'S EYE. NO PRODUCT MALFUNCTION OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL MICL13.2 NA

    Patients

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