Tekia, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0237-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

Product Classification:

Class II

Date Initiated: September 29, 2015

Date Posted: November 18, 2015

Recall Number: Z-0237-2016

Event ID: 72434

Reason for Recall:

Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

Status: Terminated

Product Quantity: 50 units

Code Information:

SN: U07310001 thru U07310040 , 07310050 thru U07310059

Distribution Pattern:

Internationally to Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated