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.
FDA Recall Z-0593-2013 · Posted 2012-12-20
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Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHQC
Date Initiated2012-08-31
Date Terminated2013-07-11
Product Quantity124 units
Reason for Recall
Posterior fluidics modules installed in the system may need to be recalibrated.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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