BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2904491 · Received January 9, 2013

    Report

    Report Number
    2023826-2013-00018
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE CODE: SIZE INCORRECT FOR PATIENT. 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. CLAIM # (B)(4).

    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. 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).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2012. THE ICL HAD A LOW VAULT AND WILL BE EXCHANGED FOR A LONGER LENS. THE REPORTER STATED THE PATIENT DID NOT HAVE ANY COMPLICATIONS RELATED TO THE LOW VAULT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER STATED THE LENS WAS EXPLANTED ON (B)(6) 2013 WITH NO PATIENT INJURY. THE ICL WAS EXCHANGED FOR A LONGER LENS. THERE WERE NO RELATED COMPLICATIONS TO THE LOW VAULT AND THE PATIENT'S BCVA AT THE POST-OP VISIT WAS 20/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11123 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK