BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2834367 · Received November 15, 2012

    Report

    Report Number
    2023826-2012-00927
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    March 3, 2011
    Report Date
    October 19, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC). (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED LENS CONFIRMED THE LENS WAS STUCK INSIDE THE CARTRIDGE. THE TIP OF THE CARTRIDGE WAS DAMAGED AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PRODUCT, THE LIKELY ROOT CAUSE OF THE EVENT IS OFF LABEL USE OF THIS LENS WITH THE NANOPOINT CARTRIDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AA4203TL SILICONE SINGLE PIECE LENS GOT STUCK IN THE CARTRIDGE AND THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED ON THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR