Tekia Recalls Intraocular Lenses Due to Incorrect Diopter Power Labeling
Tekia is recalling 50 units of Single Piece Hydrophilic Acrylic Intraocular Lenses because they may be labeled with the incorrect diopter power.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect labeling of a critical medical parameter (diopter power) for a surgical implant, which poses a risk of harm if the wrong power is implanted, even though no specific injuries are reported in the text.
Plain-English summary
Tekia, Inc. is recalling 50 units of TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811. The recall was initiated because the devices may be labeled with the incorrect diopter power.
The affected units were distributed internationally to Vietnam. The specific serial numbers involved are U07310001 through U07310040 and 07310050 through 07310059.
The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare providers and patients should verify the diopter power of the implanted lenses against the packaging to ensure the correct power was used.
The recalled product
- Product
- TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
- Manufacturer
- Tekia, Inc.
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- SN: U07310001 thru U07310040
- 07310050 thru U07310059
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Tekia, Inc.
See all →- ModerateTekia Recalls Mislabeled Hydrophilic Acrylic Intraocular Lenses
FDA (Devices) · 2019-12-25
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateTekia Recalls Mislabeled Hydrophilic Acrylic Intraocular Lenses
FDA (Devices) · 2019-12-25
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
- HighIntraocular lenses recalled after off-power error produced wrong diopter strength
FDA (Devices) · 2025-09-03
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAbbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk
FDA (Devices) · 2016-09-28