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 Insight

This FDA Devices action (record #Z-0593-2013) was formally reported on December 26, 2012, with the manufacturer initiating the action on August 31, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Bausch & Lomb Inc is listed as the recalling firm, operating out of Rochester, NY. Federal records indicate 124 units units are affected.

The documented reason for this recall is: Posterior fluidics modules installed in the system may need to be recalibrated. Distribution data in the federal record shows the product reached: 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. Ther…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.