Abbott TECNIS Intraocular Lenses Recalled for Expiration Date Violations
Johnson & Johnson Surgical Vision is recalling 17 expired Abbott TECNIS intraocular lenses distributed in seven US states.
What this means for you
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 involves a documentation/expiration date issue with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Johnson & Johnson Surgical Vision Inc is recalling 17 units of the Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00. The recall was initiated because the intraocular lenses were distributed after their expiration dates.
The affected lenses were distributed nationwide in the United States, specifically in the states of Indiana, Minnesota, North Carolina, Nevada, Texas, Washington, and West Virginia. There was no foreign, military, or government distribution. The source text does not report any illnesses or injuries associated with the use of these expired devices.
Healthcare providers and patients should check their records for the specific serial numbers and expiration dates listed in the recall notice. If an affected lens has been implanted, patients should contact their eye care provider for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular c
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Hazard
- Affected units
- 17
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)
- Item PCB00 29.5D
- Ser. #3496431503
- exp. 3/11/2018
- UDI (01)05050474558458(17)180311(21)3496431503
- Item PCB00 10.5D
- Ser. #4824531411
- exp. 10/9/2017
- UDI (01)05050474558076(17)171009(21)4824531411
- Item PCB00 11.5D
- Ser. #2354451505
- exp. 5/7/2018
- UDI (01)05050474558090(17)180507(21)2354451505
- Item PCB00 12.0D
- Ser. #3595511502
- exp. 2/14/2018
- UDI (01)05050474558106(17)180214(21)3595511502
- Ser. #3595551502
- UDI (01)05050474558106(17)180214(21)3595551502
- Item PCB00 12.5D
- Ser. #3488131502
Distribution
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