BEUDAMED
    FDA Recall Terminated

    Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.

    Recall: Z-0593-2013 · Initiated August 31, 2012

    Recall

    Recall Number
    Z-0593-2013
    Event Number
    63057
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 31, 2012
    Posted
    December 20, 2012
    Terminated
    July 11, 2013
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.

    Reason

    Posterior fluidics modules installed in the system may need to be recalibrated.

    Action

    "Urgent Product Recall" notification letters dated August 31, 2012 were issued via first class mail, e-mail, and/or phone calls to affected customers. The product issue and the field correction was provided. Customers in the US may contact 1-800 338-2020 for questions.

    Distribution

    Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, and Lebanon. There was no government or military distribution.

    Quantity

    124 units