BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 3040527 · Received April 3, 2013

    Report

    Report Number
    2023826-2013-00250
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: LENS WORK ORDER SEARCH. RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND WAS INSIDE THE CARTRIDGE. THERE IS NO VISIBLE DAMAGE TO THE CARTRIDGE. THERE WAS EVIDENCE OF REDDISH RESIDUE ON THE PRODUCT. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON USED AN AA4203TL TORIC OPTIC SILICONE SINGLE PIECE LENS. THE SURGEON WAS ADVANCING THE LENS IN THE INJECTOR WHEN IT SEEMED TO HAVE GOTTEN TWISTED INSIDE THE CARTRIDGE. THE SURGEON DID NOT FEEL COMFORTABLE USING IT. LENS WAS NOT INSERTED INTO THE PT'S EYE BUT THE TIP OF CARTRIDGE DID HAVE PT CONTACT. THERE WAS NO PT INJURY. NO LOT NUMBERS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136086 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR VISCOELASTIC: STAARVISC II, LOT NUMBER - UNK| INJECTOR: MODEL MSI-TR, LOT NUMBER - UNK| CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER - UNK