BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1923570 · Received December 2, 2010

    Report

    Report Number
    2023826-2010-01229
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (SECONDARY) - (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON IMPLANTED A CQ2015A THREE PIECE COLLAMER LENS IN (B)(6) 2010 AND THE LENS WAS EXPLANTED (B)(6) 2010 DUE TO THE REFRACTIVE AIM NOT BEING ACHIEVED. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION AND ANOTHER CQ2015A LENS WITH A 19.0 DIOPTER WAS IMPLANTED. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF THE WRONG POWER SELECTION BY THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention