Agency classClass IIOur severity:High FDA (Devices)·Z-1005-2023·Announced 2023-02-01

Veritas Advanced Infusion Packs Recalled Due to Weld Gap Defect

Johnson & Johnson Surgical Vision is recalling Veritas Advanced Infusion Packs for a weld defect that may impair vacuum delivery during ophthalmic surgery. This could result in surgical delays and transient corneal swelling.

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: This is an FDA Class II recall of a surgical device with potential for patient harm. The manufacturing defect (weld gap) could impair vacuum delivery during ophthalmic surgery, resulting in surgical delays and transient corneal edema. Although no illnesses have been reported, the risk of ocular complications in a surgical context meets the 'High' severity threshold for risk-of-harm products.

Plain-English summary

Johnson & Johnson Surgical Vision, Inc. is recalling Veritas Advanced Infusion Packs (Model VRT-AI) due to a manufacturing defect. The defect involves weld protrusion and/or physical gaps between the housing and phaco pack cover that may exceed design specifications.

The defect could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during ophthalmic surgery. This may result in surgical delay, longer surgical time, and transient corneal edema (temporary eye swelling).

Approximately 3,133 units have been distributed in the United States (Florida, Mississippi, New York, Tennessee, Texas, Illinois, Minnesota, Ohio) and internationally (Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom). Affected lot numbers are 60400378, 60401981, and 60401982.

Facilities currently using these infusion packs should discontinue use immediately and contact Johnson & Johnson Surgical Vision for replacement units or additional guidance.

The recalled product

Product: Veritas Advanced Infusion Packs, REF: VRT-AI
Manufacturer: Johnson & Johnson Surgical Vision, Inc.
Category: Medical Device — Ophthalmic Surgery
Hazard: weld-defect
vacuum-failure
corneal-edema
Affected units: 3,133

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 (3)

UDI-DI/Lots: 05050474700901/60400378
60401981
60401982

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 3 recalled by Johnson & Johnson Surgical Vision, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Johnson & Johnson Surgical Vision, Inc.

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Same hazard · weld defect