FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
- Recall number
- Z-0862-2015
- Recalling firm
- Bausch & Lomb Inc
- Product
- Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
- Status
- Terminated
- Initiated
- 2014-11-04
- Posted
- 2014-12-23
- Terminated
- 2017-03-23
- Reason
- A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Bausch & Lomb contacted customers by phone on November 4, 2014. Customers were informed of the conditions required for the device to malfunction. Customers were also notified that a software update to address the situation will be installed in their system within the next few weeks, and that the firm's service team will be scheduling a visit to each facility to install this software update. Customers were also told that in the meantime they may continue to use the device. For further questions please call (585) 338-6839.
- Quantity
- 106
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K133486"]
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 1920664
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28