Irvine, CA, United States
Tekia, Inc. recalls
1 recall recorded since 2018, most recently on 9 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 9 November 2018
- Terminated
- 16 September 2020
- Reason
- A limited number of lenses may be mislabeled with the incorrect diopter power.
- Distribution
- There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0694-2020
- TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.