Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly
Bausch & Lomb is recalling two Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a surgical device with a software defect that could lead to unintended laser firing, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Bausch & Lomb Inc is recalling two units of the Stellaris PC Vision Enhancement System with integrated laser module (BL14334 with BL2272 Laser Upgrade kit). The affected units have serial numbers SPC00747 and SPC 01918. The system is used for the surgical treatment and removal of cataractous lenses, vitreous removal, and certain treatments of the posterior portion of the eye.
The recall is due to a software anomaly where the system may automatically transition from the "Standby" state to the "Ready to Fire" state while in surgical use. This could potentially lead to unintended laser firing during a procedure.
The affected devices were distributed worldwide, including in the United States and various international locations. Healthcare providers and facilities that possess these specific serial numbers should contact Bausch & Lomb for instructions on how to address the software anomaly.
The recalled product
- Product
- Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and c
- Manufacturer
- Bausch & Lomb Inc
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers: SPC00747 and SPC 01918
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bausch & Lomb Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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