BEUDAMED
    FDA Adverse Event Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2010412 · Received February 23, 2011

    Report

    Report Number
    2023826-2011-00153
    Date Received
    February 23, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 26, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THERE WERE TEARS IN THE OPTIC AND A HAPTIC WAS TORN OFF WITH A PIECE OF THE OPTIC AND MISSING. CONCLUSION: (OTHER) - A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MFG, RELEASE TESTING, AND EVAL OF TEST RESULTS. ADDITIONALLY, THE INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS. (B)(4).

    Description of Event or Problem · 1

    THE RPTR STATED THE HAPTIC OF A (B)(4) COLLAMER THREE PIECE LENS, TORE AS THE SURGEON INSERTED IT. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURED AFTER ANOTHER SAME MODEL LENS WAS IMPLANTED.

    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 UNK STAARVISC II, LOT NUMBER UNK| CQ CARTRIDGE FP MODEL, LOT NUMBER UNK| INJECTOR: MODEL MSI-PM, LOT NUMBER UNK