Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 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 certain treatments of the posterior portion of the eye.

Class I - Dangerous

🏥 Medical Devices Recalled: November 4, 2014 Bausch & Lomb Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
Serial numbers: SPC00146, SPC00148, SPC00181, SPC00362, SPC00384, SPC00393, SPC00403, SPC00406, SPC00418, SPC00422, SPC00424, SPC00427, SPC00466, SPC00469, SPC00500, SPC00504, SPC00524, SPC00525, SPC00566, SPC00636, SPC00738, SPC00771, SPC00785, SPC00793, SPC00802, SPC00839, SPC00851, SPC00889, SPC00926, SPC00966, SPC00969, SPC01002, SPC01035, SPC01159, SPC01167, SPC01213, SPC01218, SPC01224, SPC01263, SPC01267, SPC01300, SPC01347, SPC01405, SPC01442, SPC01446, SPC01447, SPC01449, SPC01466, SPC01474, SPC01492, SPC01542, SPC01573, SPC01608, SPC01629, SPC01653, SPC01655, SPC01666, SPC01667, SPC01678, SPC01681, SPC01687, SPC01696, SPC01699, SPC01707, SPC01732, SPC01742, SPC01746, SPC01749, SPC01750, SPC01752, SPC01754, SPC01756, SPC01760, SPC01816, SPC01817, SPC01819, SPC01820, SPC01843 and SPC01884
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Bausch & Lomb Inc
Reason for Recall:: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 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 certain treatments of the posterior portion of the eye.

Product Codes/Lot Numbers:

Serial numbers: SPC00146, SPC00148, SPC00181, SPC00362, SPC00384, SPC00393, SPC00403, SPC00406, SPC00418, SPC00422, SPC00424, SPC00427, SPC00466, SPC00469, SPC00500, SPC00504, SPC00524, SPC00525, SPC00566, SPC00636, SPC00738, SPC00771, SPC00785, SPC00793, SPC00802, SPC00839, SPC00851, SPC00889, SPC00926, SPC00966, SPC00969, SPC01002, SPC01035, SPC01159, SPC01167, SPC01213, SPC01218, SPC01224, SPC01263, SPC01267, SPC01300, SPC01347, SPC01405, SPC01442, SPC01446, SPC01447, SPC01449, SPC01466, SPC01474, SPC01492, SPC01542, SPC01573, SPC01608, SPC01629, SPC01653, SPC01655, SPC01666, SPC01667, SPC01678, SPC01681, SPC01687, SPC01696, SPC01699, SPC01707, SPC01732, SPC01742, SPC01746, SPC01749, SPC01750, SPC01752, SPC01754, SPC01756, SPC01760, SPC01816, SPC01817, SPC01819, SPC01820, SPC01843 and SPC01884