BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3013906 · Received March 20, 2013

    Report

    Report Number
    2023826-2013-00201
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SIZE INCORRECT FOR PATIENT. EVALUATION METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A LOW VAULT IN THIS PATIENT ASSOCIATED WITH LENS DECENTRATION. THE ICL WAS EXCHANGED WITH A LONGER LENS WHICH RESOLVED THE PROBLEM. 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. STAAR 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. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, THE ROOT CAUSE OF INADEQUATE VAULTING HAS BEEN DETERMINED TO BE RELATED TO THE INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS TO SULCUS DIAMETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER STATED THE ICL WAS EXPLANTED ON (B)(6) 2013 DUE TO A LOW VAULT. THE ICL WAS REMOVED THROUGH THE ORIGINAL INCISION AND ONE SUTURE WAS REQUIRED TO CLOSE THE INCISION. THE PATIENT DID NOT HAVE ANY COMPLICATIONS RELATED TO THE LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENS.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2013. THE ICL DECENTERED AND WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116375 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK