Events

Recall of Device Recall Bausch Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63057
  • Event Risk Class
    Class 2
  • Event Number
    Z-0593-2013
  • Event Initiated Date
    2012-08-31
  • Event Date Posted
    2012-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112398
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, phacofragmentation - Product Code HQC
  • 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.

Device

Device Recall Bausch Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM)
  • Model / Serial
    Installed by field service 1/3/12-8/8/12. Serial numbers: PFM00034, PFM00038, PFM00043, PFM00047, PFM00052, PFM00056, PFM00063, PFM00067, PFM00076, PFM00082, PFM00085, PFM00099, PFM00102, PFM00110, PFM00131, PFM00134, PFM00140, PFM00141, PFM00142, PFM00143, PFM00160, PFM00163, PFM00168, PFM00170, PFM00174, PFM00175, PFM00177, PFM00182, PFM00183, PFM00194, PFM00197, PFM00201, PFM00203, PFM00204, PFM00232, PFM00233, PFM00239, PFM00245, PFM00246, PFM00249, PFM00263, PFM00265, PFM00271, PFM00276, PFM00278, PFM00285, PFM00293, PFM00297, PFM00299, PFM00305, PFM00313, PFM00323, PFM00327, PFM00333, PFM00334, PFM00336, PFM00338, PFM00350, PFM00365, PFM00401, PFM00410, PFM00412, PFM00413, PFM00419, PFM00427, PFM00428, PFM00429, PFM00438, PFM00439, PFM00442, PFM00455, PFM00458, PFM00470, PFM00472, PFM00474, PFM00480, PFM00490, PFM00505, PFM00511, PFM00515, PFM00526, PFM00534, PFM00536, PFM00543, PFM00545, PFM00551, PFM00552, PFM00561, PFM00563, PFM00566, PFM00577, PFM00586, PFM00598, PFM00606, PFM00614, PFM00619, PFM00643, PFM00646, PFM00656, PFM00660, PFM00667, PFM00668, PFM00684, PFM00685, PFM00690, PFM00713, PFM00717, PFM00725, PFM00751, PFM00757, PFM00769, PFM00770, PFM00775, PFM00784, PFM00786, PFM00787, PFM00812, PFM00821, PFM00831, PFM00881, PFM00884, PFM00918, PFM00923, and PFM00930
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • Manufacturer Address
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA