Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0464-2019·Announced 2018-11-21

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.

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 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…
Manufacturer: Johnson & Johnson Surgical Vision Inc
Category: Medical Device — Intraocular Lens
Hazard: expired-product
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

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Johnson & Johnson Surgical Vision Inc

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Same hazard · expired product