BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1111737 · Received August 13, 2008

    Report

    Report Number
    2023826-2008-01053
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    July 15, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS PORTIONS OF THE HAPTICS ARE TORN OFF AND MISSING. CLEAR SURGICAL RESIDUE ON THE LENS. A WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND NO SIMILAR COMPLAINTS WERE 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 INADEQUATE VAULT. IF PREDICTED LENGTH IS TOO LONG, THE RESULT MAY BE AN EXCESSIVE VAULT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A VISION ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 12.6MM IN 2008, AND EXPLANTED THE LENS ON THE FOLLOWING MONTH, DUE TO AN EXCESSIVE VAULT OF THE LENS CAUSING AN ELEVATED IOP AND AN ANGLE CLOSURE AND A SHALLOWING OF THE ANTERIOR CHAMBER DEPTH. THE SURGEON PERFORMED A LIMBAL RELAXING INCISION TO RELIEVE THE IOP PRIOR TO REMOVING THE LENS. THE PATIENT'S PRE-OP INFORMATION STATES THE PT'S WHITE TO WHITE MEASURED AT 11.5MM. THE SURGEON WILL IMPLANT ANOTHER LENS AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOAM TIP PLUNGER: UNK| INJECTOR MODEL: UNK| CARTRIDGE MODEL: SFC-45FP