Johnson & Johnson Recalls Nonconforming TECNIS Toric Intraocular Lenses
Johnson & Johnson Surgical Vision Inc is recalling 27 TECNIS Toric 1-Piece Intraocular Lenses due to the release of nonconforming products.
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Johnson & Johnson Surgical Vision Inc is recalling 27 units of the TECNIS Toric 1-Piece Intraocular Lens (IOL), Model Number ZCT150 +23.5D SE 1.50D CYL. The recall was initiated due to the release of nonconforming intraocular lenses.
The affected lenses are intended to be placed in the capsular bag. The specific lot number is 8144121847, and the UDI/GTIN codes are (01)05050474552210(17)221123(21)8144121847 and 5050474552210. The expiration date associated with the UDI is November 23, 2022.
The product was distributed nationwide in the United States, specifically in the states of Alabama, Arizona, California, Florida, Georgia, Illinois, Louisiana, Michigan, Minnesota, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington. Healthcare providers and patients should contact the manufacturer for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Hazard
- Affected units
- 27
Distribution
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