The Recall Desk

FDA (Devices) recall action 69717

Bausch & Lomb Inc recalled 3 products on 2014-12-31

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-12-31
Critical
0
Units
187

Why these products were recalled

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    21 states
  • HighFDA (Devices)··2014-12-31

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

    Bausch & Lomb is recalling two Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    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 c
    Category
    Distribution
    21 states
  • HighFDA (Devices)··2014-12-31

    Bausch & Lomb Stellaris PC Laser Recall for Software Anomaly

    Bausch & Lomb is recalling 106 Stellaris PC laser systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
    Category
    Distribution
    21 states