BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3140677 · Received May 31, 2013

    Report

    Report Number
    2023826-2013-00438
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO - 81 (OTHER): LENS WAS DISCARDED. METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    RESULTS: MEDICAL REVIEW - REPORTEDLY ICL WAS EXPLANTED/EXCHANGED FOR A SHORTER LENS TWO WEEKS POSTOPERATIVELY TO ADDRESS ELEVATED IOP( NO VALUE PROVIDED).AFTER THE INTERVENTION THE IOP WAS 14MMHG. ACCORDING TO THE REPORT THE EXACT CAUSE OF THE EVENT WAS UNKNOWN. GIVEN THE INFORMATION THAT SHORTER LENS RESOLVED THE ISSUE THE MOST LIKELY REASON WAS PATIENT RELATED FACTOR(ANATOMY),COMBINED WITH PROCEDURE RELATED FACTORS ((B)(4)). CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, 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 MICL 13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2013. THE LENS WAS EXPLANTED ON (B)(6) 2013, DUE TO ELEVATED IOP. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND WAS DISCARDED. THE LENS WAS EXCHANGED WITH A SHORTER LENS. THE IOP AFTER EXPLANT AND EXCHANGE WAS 14MM AND THE PATIENT IS VERY HAPPY WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241509 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK.| CARTRIDGE MODEL-SFC-45, LOT#-UNK.| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK.| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.| INJECTOR MODEL MSI-PF - LOT NUMBER UNK.| INJECTOR MODEL-MSI-PF, LOT#-UNK.| INJECTOR MODEL MSI-PF - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK