Recall Z-0863-2015— Bausch & Lomb Inc
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Inc, initiated 2014-11-04, terminated 2017-03-23. It names one FDA 510(k) clearance: K133486. 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 certain treatments of the posterior portion of the eye.. Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use..
- Recalling firm
- Bausch & Lomb Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-04
- Terminated
- 2017-03-23
- Firm location
- Saint Louis, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.