BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2443849 · Received February 3, 2012

    Report

    Report Number
    2023826-2012-00083
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 6, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK OTHER SEARCH, MEDICAL REVIEW. RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF PLATE HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED DRY. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PATIENT HAD A 12.6-9.5D ICL IMPLANTED AND 1 DAY POST-OP, THE IOP WAS 60 WHICH DROPPED TO 19 AFTER THE WOUND WAS BURPED. THIS CONDITION IS DUE TO RETAINED VISCOELASTIC, WHICH IS TEMPORARY. THE VAULT AFTER A WEEK WAS ASSESSED TO BE 100UM AND THE SURGEON EXCHANGED THE ICL FOR A 13.2-9.5D 4 MONTHS AFTER INITIAL IMPLANTATION. THE CONDITION RESOLVED AFTER THE EXCHANGE. IT HAS BEEN DETERMINED THAT THIS COMPLICATION IS RELATED TO INACCURATE WHITE TO WHITE MEASUREMENT OR SECONDARY TO A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS DIAMETER. SURGEONS ARE ADVISED TO OBSERVE THE PATIENT FOR ANY SIGNS OR SYMPTOMS OF PROGRESSIVE ANTERIOR SUBCAPSULAR CATARACT FORMATION PRIOR TO EXCHANGING THIS LENS. STARR RECOMMENDS THAT THE LENS BE EXPLANTED ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT OUTCOME OF THE PATIENT'S VISION. IF NO OTHER SYMPTOMS ARE OBSERVED, IT IS RECOMMENDED TO LEAVE THE ICL IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PATIENT RIGHT EYE. THE LENS WAS REMOVED AND EXCHANGED DUE TO A LOW VAULT AND ELEVATED IOP. IT WAS EXCHANGED FOR A LONGER LENGTH LENS.

    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 41 YR Required Intervention CARTRIDGE MODEL: LOT NUMBER - UNK| INJECTOR MODEL: LOT NUMBER - UNK| FOAM TIP PLUNGER MODEL: LOT NUMBER - UNK