Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
Country not established
- Devices
- 2
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Alcon Research, Ltd. Dba Alcon Laboratories, Inc. makes
Alcon Laboratories, Inc. manufactures excimer laser systems designed for refractive corneal surgery, including the WAVELIGHT FS200 Laser System and the SVS APEX Plus Excimer Laser Workstation. These devices are used for procedures such as photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) to correct vision impairments. The systems incorporate advanced laser technology for precision ablation of corneal tissue.
The company’s portfolio includes devices classified under FDA regulations as Class II and Class III, with authorisations granted through the 510(k) and PMA pathways. These products are listed in the FDA’s regulatory databases and are intended for use in the United States. The company operates under its US-based subsidiary, Alcon Laboratories, Inc.
Catalogue
Wavelight FS200 Laser System Ref K141476
Regimes: 510(k) Registry: 510(k)Svs Apex Plus Excimer Laser Workstation Ref P910067
Regimes: PMA, withdrawn Registry: PMA
FDA recalls
FDA recall records list 11 recalls initiated by Alcon Research, Ltd. Dba Alcon Laboratories, Inc., initiated on 2010-04-30. By recorded status: 11 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 30 Apr 2010 Z-1924-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1925-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1926-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1927-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1928-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1929-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1930-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1931-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1932-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- 30 Apr 2010 Z-1933-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Show all 11 recalls
2010
- 30 Apr 2010 Z-1934-2010 Unclassified (pre-2012) Terminated Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
Frequently asked questions
How many devices does Alcon Research, Ltd. Dba Alcon Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Alcon Research, Ltd. Dba Alcon Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alcon Research, Ltd. Dba Alcon Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Alcon Research, Ltd. Dba Alcon Laboratories, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alcon Research, Ltd. Dba Alcon Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Alcon Research, Ltd. Dba Alcon Laboratories, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Alcon Research, Ltd. Dba Alcon Laboratories, Inc.?
FDA recall records list 11 recalls initiated by Alcon Research, Ltd. Dba Alcon Laboratories, Inc., the most recent initiated on 30 Apr 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Alcon Research, Ltd. Dba Alcon Laboratories, Inc. in the registry?
The most recently registered devices listed for Alcon Research, Ltd. Dba Alcon Laboratories, Inc. include WAVELIGHT FS200 LASER SYSTEM and SVS APEX PLUS EXCIMER LASER WORKSTATION.