Alcon Lensx, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Alcon Lensx, Inc. makes
Alcon Lensx, Inc. makes the LenSx Laser System, a femtosecond laser system used in ophthalmic surgery for cataract and refractive procedures.
The LenSx Laser System is classified as a Class II medical device and is listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Lenssx Laser System Ref K120732
Regimes: 510(k) Registry: 510(k)Lensx Laser System Ref K123120
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Alcon Lensx, Inc., initiated on 2014-03-14. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 14 Mar 2014 Z-1445-2014 Class II Terminated Alcon LenSx received reports of unexpected downward motion of the gantry.
Frequently asked questions
How many devices does Alcon Lensx, Inc. have in the registry?
The registry currently lists 2 devices for Alcon Lensx, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alcon Lensx, Inc.'s devices?
Among its 2 most recently registered devices, Alcon Lensx, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Alcon Lensx, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Alcon Lensx, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alcon Lensx, Inc.?
FDA recall records list 1 recall initiated by Alcon Lensx, Inc., the most recent initiated on 14 Mar 2014. 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 Lensx, Inc. in the registry?
The most recently registered devices listed for Alcon Lensx, Inc. include LENSSX LASER SYSTEM and LENSX LASER SYSTEM.