BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1923573 · Received December 6, 2010

    Report

    Report Number
    2023826-2010-01232
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (SECONDARY SURGERY) - (B)(4) (EXCESSIVE), (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 13.0MM ICM130V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 IN PATIENT'S LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PATIENT HAD NARROWING OF THE ANGLE, POSSIBLE ANGLE CLOSURE AND SHALLOWING OF THE ACD. THE LENS WAS EXCHANGED FOR A SHORTER LENS. SEE MFR#2023826-2010-01233 FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM130V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK