Tekia, Inc.
United States US-MF-000020955 Last updated 23 Oct 2026
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- Devices
- 10
- Registries
- EUDAMEDFDA
- FDA recalls
- 3
Catalogue
Tek-Lens II Ref 872
MeyeLens Ref 360
Ophthalmo Pro Ref AC 3000 HD
Tek-Lens II Ref 618Y
Tek-Clear Ref 500S
Tek-Lens III Ref Model 900
Tek-Lens II Ref 811
Tek-Lens II Ref 617Y
Tek-Lens II Ref 872YS
Tek-Lens II Ref 618
Related companies
Authorised representatives
- Caliceos FR
FDA recalls
Tekia, Inc. has three FDA recall records, all initiated between July 2, 2004, and November 9, 2018, with each record marked as terminated. The recalls involve intraocular lenses (IOLs), specifically noting mislabeling where lenses with powers of 17.0 D and 22.5 D were incorrectly swapped, and a broader recall of Single Piece Hydrophilic Acrylic IOLs due to potential incorrect diopter power labeling.
2018
- 9 Nov 2018 Z-0694-2020 Class II Terminated A limited number of lenses may be mislabeled with the incorrect diopter power.
2015
- 29 Sep 2015 Z-0237-2016 Class II Terminated Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
2004
- 2 Jul 2004 Z-1311-06 Unclassified (pre-2012) Terminated Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.
What Tekia, Inc. makes
Tekia, Inc. manufactures a range of contact lenses, including the Tek-Lens II, Tek-Lens III, MeyeLens, and Tek-Clear, designed for ophthalmic applications. These products are intended for use in correcting vision or managing ocular conditions, with some models likely tailored for specific patient needs such as extended wear or therapeutic purposes.
The company’s devices fall under EU Class IIb classification and are registered in the EUDAMED database. Tekia, Inc. is based in the United States, and its products are authorised for distribution within the European Economic Area through this regulatory listing.
Frequently asked questions
What types of medical devices does Tekia, Inc. manufacture?
Tekia, Inc. specializes in ophthalmic devices, specifically a range of contact lenses. Their portfolio includes products like the Tek-Lens II, Tek-Lens III, MeyeLens, and Tek-Clear, which are designed for vision correction or managing ocular conditions. These lenses are intended for use in clinical or patient settings where precise ocular care is required.
Where is Tekia, Inc. based, and what region does it serve with its devices?
Tekia, Inc. is headquartered in the United States. While the company originates from the US, its devices are authorised for distribution and use within the European Economic Area (EEA). This regulatory alignment is reflected in their inclusion in the EUDAMED database.
Which regulatory registries list Tekia, Inc.’s devices, and why?
Tekia, Inc.’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This listing is required for devices authorised in the EEA, ensuring transparency and compliance with EU regulations. Since their products fall under Class IIb classification, they must meet stricter safety and performance standards, necessitating registration in this system.
How are Tekia, Inc.’s devices classified under EU regulations?
Tekia, Inc.’s devices are classified as Class IIb under EU medical device regulations. This classification applies to products that pose a moderate to high risk, such as certain contact lenses, which require additional scrutiny to ensure safety and efficacy. Class IIb devices must undergo rigorous conformity assessment procedures before being authorised for market placement.
Information
- Country
- United States
- Address
- 17 Hammond Street, Irvine, United States
- Website
- www.tekia.com
- [email protected]
- Phone
- +1 9496991300
- PRRC contact
- Catherine Chaudron
- EUDAMED SRN
- US-MF-000020955
- FDA FEI number
- 3002023310