BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2023836 · Received March 8, 2011

    Report

    Report Number
    2023826-2011-00190
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    December 28, 2010
    Report Date
    February 23, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SECONDARY SURGERY, IRRIGATION OF ANTERIOR CHAMBER. (B)(4) - EXCESSIVE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 IN PATIENT'S LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO EXCESSIVE VAULTING ASSOCIATED WITH ELEVATED IOP. IRRIGATION OF ANTERIOR CHAMBER OF REMAINING VISCO/FLUIDS WAS PERFORMED. A SHORTER LENS WAS IMPLANTED ON (B)(6) 2011. PATIENT'S LAST VISIT WAS ON (B)(6) 2011 BCVA 20/20.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK