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.
Reported: December 26, 2012 Initiated: August 31, 2012 #Z-0593-2013
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.
Reason for Recall
Posterior fluidics modules installed in the system may need to be recalibrated.
Details
- Recalling Firm
- Bausch & Lomb Inc
- Units Affected
- 124 units
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bausch & Lomb Inc. Units affected: 124 units.
Why was this product recalled? ▼
Posterior fluidics modules installed in the system may need to be recalibrated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0593-2013.
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