Reported Dec 31, 2014 · Terminated
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit)…
Bausch & Lomb Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb Inc · 3365 Tree Court Industrial Blvd · Saint Louis, MO · 63122-6615
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers
78 of 78 codes
SPC00146SPC00148SPC00181SPC00362SPC00384SPC00393SPC00403SPC00406SPC00418SPC00422SPC00424SPC00427SPC00466SPC00469SPC00500SPC00504SPC00524SPC00525SPC00566SPC00636SPC00738SPC00771SPC00785SPC00793SPC00802SPC00839SPC00851SPC00889SPC00926SPC00966SPC00969SPC01002SPC01035SPC01159SPC01167SPC01213SPC01218SPC01224SPC01263SPC01267SPC01300SPC01347SPC01405SPC01442SPC01446SPC01447SPC01449SPC01466SPC01474SPC01492SPC01542SPC01573SPC01608SPC01629SPC01653SPC01655SPC01666SPC01667SPC01678SPC01681
- Serial numbers
- Amount recalled
- 79
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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