CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report

Stellaris PC w/ Laser, BL14304 The responsible firm name recalled

Bausch & Lomb is recalling Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated, distributed in 21 states. The recall was initiated on 4 Nov 2014 and the FDA has classified it as Class II.

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Lot, batch or date codesSerial numbers: SPC01790, SPC01791, SPC01792, SPC01793, SPC01794, SPC01795, SPC01796, SPC01797, SPC01798, SPC01799, SPC01800, SPC01801, SPC01802, SPC01803, SPC01806, SPC01807, SPC01808, SPC01809, SPC01810, SPC01811, SPC01899, SPC01900, SPC01901, SPC01902, SPC01903, SPC01909, SPC01910, SPC01911, SPC01920, SPC01921, SPC01922, SPC01923, SPC01927, SPC01928, SPC01929, SPC01930, SPC01931, SPC01932, SPC01939, SPC01943, SPC01944, SPC01945, SPC01946, SPC01947, SPC01948, SPC01950, SPC01951, SPC01952, SPC01953, SPC01954, SPC01955, SPC01956, SPC01957, SPC01958, SPC01961, SPC01963, SPC01968, SPC01969, SPC01975, SPC01980, SPC01981, SPC01982, SPC01983, SPC01995, SPC01996, SPC01997, SPC02004, SPC02005, SPC02006, SPC02007, SPC02008, SPC02009, SPC02010, SPC02011, SPC02012, SPC02013, SPC02014, SPC02020, SPC02029, SPC02030, SPC02037, SPC02043, SPC02051, SPC02052, SPC02053, SPC02056, SPC02057, SPC02059, SPC02061, SPC02067, SPC02068, SPC02073, SPC02074, SPC02075, SPC02076, SPC02077, SPC02099, SPC02108, SPC02109, SPC02110, SPC02111, SPC02112, SPC02113, SPC02114, SPC02115 and SPC02120

Quantity recalled106

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-0862-2015
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: Other Medical Devices

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, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

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.

Alabama California Connecticut Florida Georgia Hawaii Illinois Indiana Kansas Michigan Minnesota Missouri Mississippi New Hampshire New York Ohio Oklahoma Pennsylvania Texas Wisconsin

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: SPC01790, SPC01791, SPC01792, SPC01793, SPC01794, SPC01795, SPC01796, SPC01797, SPC01798, SPC01799, SPC01800, SPC01801, SPC01802, SPC01803, SPC01806, SPC01807, SPC01808, SPC01809, SPC01810, SPC01811, SPC01899, SPC01900, SPC01901, SPC01902, SPC01903, SPC01909, SPC01910, SPC01911, SPC01920, SPC01921, SPC01922, SPC01923, SPC01927, SPC01928, SPC01929, SPC01930, SPC01931, SPC01932, SPC01939, SPC01943, SPC01944, SPC01945, SPC01946, SPC01947, SPC01948, SPC01950, SPC01951, SPC01952, SPC01953, SPC01954, SPC01955, SPC01956, SPC01957, SPC01958, SPC01961, SPC01963, SPC01968, SPC01969, SPC01975, SPC01980, SPC01981, SPC01982, SPC01983, SPC01995, SPC01996, SPC01997, SPC02004, SPC02005, SPC02006, SPC02007, SPC02008, SPC02009, SPC02010, SPC02011, SPC02012, SPC02013, SPC02014, SPC02020, SPC02029, SPC02030, SPC02037, SPC02043, SPC02051, SPC02052, SPC02053, SPC02056, SPC02057, SPC02059, SPC02061, SPC02067, SPC02068, SPC02073, SPC02074, SPC02075, SPC02076, SPC02077, SPC02099, SPC02108, SPC02109, SPC02110, SPC02111, SPC02112, SPC02113, SPC02114, SPC02115 and SPC02120

Where was it sold?

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

This product is part of a recall event; the main page for the event is Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 recalled.

Reported	Class	Recall	Company	Reason	Where
31 Dec 2014	CLASS II	Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 recalled	Bausch & Lomb	Device Malfunction	21 states
31 Dec 2014	CLASS II	Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 recalled	Bausch & Lomb	Device Malfunction	21 states

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