Facility

TEKIA, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002023310
Establishment type	Manufacture Device in the United States for Export Only
Location	17 Hammond Irvine, CA, US 92618
Registration status	Active · expires 2026
Parent company	TEKIA, INC (owner-operator 10023535)
Brand names	TEKTOR Single Piece Acrylic Toric IOLs Model 820 &820Y; TEK-CLEAR Accommodative IOLs Model 500 Series; TEKLENS II Single Piece Hydrophlic Acrylic IOLs Model 800 & 800Y Series; TEKLENS III Hydrophobic Acrylic IOLs Model 900 series; TEKLENS II Three Piece Hydrophlic Acrylic IOLs Model 600 & 600Y Series

Activity by year

Recalls (2)

Devices registered here (1)

Intraocular Lens
Product code HQL (opens in a new tab) · Class III · Ophthalmic · 21 CFR 886.3600

Recalls & enforcement

Class IITerminated2018-11-09
A limited number of lenses may be mislabeled with the incorrect diopter power.
Class IITerminated2015-09-29
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

All facilities operated by TEKIA, INC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “TEKIA, INC. (FEI 3002023310) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002023310-tekia-inc/

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