Tekia Recalls Mislabeled Hydrophilic Acrylic Intraocular Lenses
Tekia, Inc. is recalling 36 intraocular lenses that may be mislabeled with the incorrect diopter power. No U.S. distribution occurred.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect diopter power) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tekia, Inc. is recalling a limited number of TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The recall is due to the possibility that a limited number of these lenses may be mislabeled with the incorrect diopter power.
The recall involves 36 units from Lot 522-003 that were within their expiration date. A total of 81 lenses were distributed, but the remaining 45 were past their expiration date and are not part of this recall. There was no distribution of these products within the United States. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
Consumers and healthcare providers in the affected foreign countries should contact Tekia, Inc. for further information. The specific serial numbers of the recalled lenses are listed in the official recall notice.
The recalled product
- 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.
- Manufacturer
- Tekia, Inc.
- Hazard
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 (20)
- 36 recalled serial numbers from Lot 522-003: U12220229
- U12220230
- U12220231
- U12220232
- U12220233
- U12220234
- U12220235
- U12220236
- U12220237
- V01110221
- V01110222
- V01110223
- V01110224
- V02200066
- V02200067
- V02200068
- V02200069
- V02200070
- V02200071
- V03190037
Distribution
Distribution scope not specified by the agency.
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