CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 recalled
Bausch & Lomb is recalling Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4, distributed in 21 states. The recall was initiated on 4 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0864-2015
- FDA event ID
- 69717
- Recalling firm
- Bausch & Lomb, Saint Louis, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 4 Nov 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +49 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 certain treatments of the posterior portion of the eye.
Where it was distributed
Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Italy, Jordan, Malaysia, Morocco, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates.
AlabamaCaliforniaConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKansasMichiganMinnesotaMissouriMississippiNew HampshireNew YorkOhioOklahomaPennsylvaniaTexasWisconsin
Questions about this recall
Why was it recalled?
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Which lots are affected?
Serial numbers: SPC00747 and SPC 01918
Where was it sold?
Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Italy, Jordan, Malaysia, Morocco, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 69717| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 recalled | Bausch & Lomb | Device Malfunction | 21 states | |
| CLASS II | Stellaris PC w/ Laser, BL14304 The responsible firm name recalled | Bausch & Lomb | Device Malfunction | 21 states |
More recalls from Bausch & Lomb
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile recalledLotemax | Bausch & Lomb | Potency & Assay | Nationwide |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vit Cutter recalled | Bausch & Lomb | Packaging Defects | 26 states |
Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |