BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1994404 · Received February 8, 2011

    Report

    Report Number
    2023826-2011-00120
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 17, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS DRY AND STUCK IN THE VIAL, UNABLE TO EVALUATE THE LENS WITHOUT DAMAGING IT. THERE WAS EVIDENCE OF DARK RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO THE DOCTOR CHANGING HIS MIND FOR ANOTHER LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), INCISION SUTURED, (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS INSERTING A (B)(4) COLLAMER ASPHERIC THREE PIECE LENS BUT CHANGED HIS MIND FOR AN ANTERIOR CHAMBER LENS, WHICH WAS IMPLANTED. THERE WAS PT CONTACT AND SUTURES WERE REQUIRED.

    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 COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK