BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2802791 · Received October 24, 2012

    Report

    Report Number
    2023826-2012-00827
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A LOW OR NO VAULT IN THIS PATIENT HOWEVER NO OTHER SIGNS OR SYMPTOMS WERE OBSERVED. 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. SURGEONS ARE ADVISED TO OBSERVE THE PATIENT FOR ANY SIGNS OR SYMPTOMS OF PROGRESSIVE ANTERIOR SUBCAPSULAR CATARACT FORMATION PRIOR TO EXCHANGING THIS LENS. 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. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, 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): EVALUATION: METHOD - WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS. THE REPORTER STATED THE PATIENT DID NOT HAVE ANY COMPLICATIONS RELATED TO THE LOW VAULTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK