BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1101886 · Received August 7, 2008

    Report

    Report Number
    2023826-2008-01028
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 16, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE OPTIC WAS TORN AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS HAVING DIFFICULTY LOADING A MICL12.6 IMPLANTABLE COLLAMER LENS AND IT WAS INSERTED UPSIDE DOWN. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A SUTURE CLOSED THE WOUND. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR.

    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 UNK Required Intervention CARTRIDGE MODEL SFC-45 FP| FOAM TIP PLUNGER MODEL| INJECTOR MODEL MIS-PF