The Recall Desk
HighFDA (Devices)·Z-0863-2015·Announced 2014-12-31

Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly

Bausch & Lomb is recalling 79 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 high-risk medical device where a software anomaly could lead to unintended laser firing during surgery, representing a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Bausch & Lomb Inc is recalling 79 units of the Stellaris PC Vision Enhancement System with integrated laser module (BL1433 with BL2272 Laser Upgrade kit). 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.

The affected devices are used for the surgical treatment and removal of cataractous lenses, vitreous removal, and certain treatments of the posterior portion of the eye. The recall covers units distributed worldwide, including in the United States and various international locations.

Healthcare providers and consumers should stop using the affected devices immediately and contact Bausch & Lomb Inc for further instructions. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

Product
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 cert
Manufacturer
Bausch & Lomb Inc
Category
Medical Device — Ophthalmic Surgical Equipment
Hazard
Affected units
79

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 (20)

  • Serial numbers: SPC00146
  • SPC00148
  • SPC00181
  • SPC00362
  • SPC00384
  • SPC00393
  • SPC00403
  • SPC00406
  • SPC00418
  • SPC00422
  • SPC00424
  • SPC00427
  • SPC00466
  • SPC00469
  • SPC00500
  • SPC00504
  • SPC00524
  • SPC00525
  • SPC00566
  • SPC00636

Distribution

Distributed in 21 states:

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.

See all 3 products in this recall →

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