Carl Zeiss Ophthalmic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Visucam Ref K021787
Regimes: 510(k) Registry: 510(k)Humphrey OCT3 Ref K012727
Regimes: 510(k) Registry: 510(k)
FDA recalls
2004
- 3 Jun 2004 Z-1066-04 Unclassified (pre-2012) Terminated The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal bleeding and burns may result.
Frequently asked questions
How many devices does Carl Zeiss Ophthalmic Systems, Inc. have in the registry?
The registry currently lists 2 devices for Carl Zeiss Ophthalmic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carl Zeiss Ophthalmic Systems, Inc.'s devices?
Among its 2 most recently registered devices, Carl Zeiss Ophthalmic Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Carl Zeiss Ophthalmic Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Carl Zeiss Ophthalmic Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Carl Zeiss Ophthalmic Systems, Inc.?
FDA recall records list 1 recall initiated by Carl Zeiss Ophthalmic Systems, Inc., the most recent initiated on 3 Jun 2004. 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 Carl Zeiss Ophthalmic Systems, Inc. in the registry?
The most recently registered devices listed for Carl Zeiss Ophthalmic Systems, Inc. include VISUCAM and HUMPHREY OCT3.