BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1911710 · Received November 16, 2010

    Report

    Report Number
    2023826-2010-01146
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (SECONDARY) - (B)(4): 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 PATIENT IS TO MEASURE WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH AND, THROUGH CORRELATIVE ALGORITHMS, 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 THE PREDICTED LENGTH IS TOO LONG, THE RESULT MAY BE AN EXCESSIVE VAULT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON IMPLANTED THE MICL12.6 IMPLANTABLE COLLAMER LENS ON (B)(6) 2010, AND A COUPLE DAYS POST-OP THE SURGEON NOTED THERE WAS NO VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PATIENT IS DOING FINE NOW. SEE MFR REPORT #2023826-2010-01147 FOR THE OTHER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention FOAM TIP PLUNGER: MODEL #UNK, LOT #UNK| CARTRIDGE: MODEL #SFC-45FP, LOT #UNK| INJECTOR: MODEL #MSI-PF, LOT #UNK