FDA recall Z-0694-2020

Tekia, Inc. · Class II · device

Product

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

Reason for recall

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.

Key facts

Status
Terminated
Initiation date
2018-11-09
Report date
2019-12-25
Termination date
2020-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0694-2020