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.
What this means for you
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.
- Hazard
- weld-defect
- vacuum-failure
- corneal-edema
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:
- FL
- IL
- MN
- MS
- NY
- OH
- TN
- TX
Related recalls
Same category
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01