Veritas Advanced Infusion Packs Recalled for Broken Irrigation Luer
Johnson & Johnson Surgical Vision is recalling 53,624 units of Veritas Advanced Infusion Packs due to manufacturing defects causing broken or cracked irrigation luers that could compromise ophthalmic surgical procedures.
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 medical device recall for a manufacturing defect in surgical equipment. The broken or cracked irrigation luer poses a risk of harm to patients and surgical outcomes during ophthalmic procedures. No injuries or complications have been reported in the source material, meeting the criterion for a high-severity recall of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Johnson & Johnson Surgical Vision, Inc. is recalling Veritas Advanced Infusion Packs, medical devices used in ophthalmic (eye) surgical procedures. The recall affects 53,624 units distributed worldwide.
The recall was initiated due to a manufacturing issue resulting in broken or cracked irrigation luers on the affected units. The irrigation luer is critical to fluid delivery during eye surgery, and the defect could compromise the functionality of the infusion system during surgical procedures.
Affected infusion packs carry Part Number VRT-AI and 52 specific lot numbers ranging from 60316112 to 60369609. The devices were distributed worldwide to hospitals and surgical centers in multiple U.S. states and over 30 countries including Canada, Australia, Europe, Asia, and the Middle East.
Healthcare providers should inspect devices before use, cease use of affected lots, and contact Johnson & Johnson Surgical Vision, Inc. for replacement units or removal from inventory.
The recalled product
- Product
- Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- Affected units
- 53,624
Distribution
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