BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 845391 · Received May 3, 2007

    Report

    Report Number
    2023826-2007-00752
    Event Type
    Injury
    Date Received
    May 3, 2007
    Date of Event
    December 22, 2006
    Report Date
    April 6, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT WAS PERFORMED AND NO VISIBLE DAMAGE WAS FOUND TO THE LENS. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT 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 SUCUS, 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. EVALUATION OF NEWLY AVAILABLE, ALTERNATE MEASURING DEVICES IS ONGOING.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN 2006. THE LENS WAS EXPLANTED FOUR MONTHS LATER DUE TO INADEQUATE VAULTING. THE PATIENT WAS COMPLAINING OF HALOS AT NIGHT. THE LENS WAS REMOVED THROUGH THE ORIGINAL INCISION AND A LONGER ICL WAS IMPLANTED. THE PATIENT'S BEST CORRECTED VISUAL ACUITY IS 20/15 AND THE PATIENT IS DOING VERY WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention INJECTOR MODEL MSI-PF-LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER| LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP-LOT NUMBER UNK