VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect
Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye 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 Class II medical device recall carries risk of patient harm through corneal edema, though no illnesses or injuries have been reported. The hazard is a specific manufacturing defect with a clear chain of consequences, meeting the rubric criterion for 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 (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF), affecting 148,941 units distributed worldwide. The recall involves specific lot numbers identified by the FDA, which were within their expiration dates as of May 29, 2023.
The recall is due to a manufacturing issue causing weld protrusions or physical gaps between the housing and pack cover that may exceed design specifications. These defects could impair the packs' ability to prime properly or deliver adequate vacuum pressure to surgical instruments during phacoemulsification and irrigation/aspiration procedures.
When affected packs malfunction, surgeons may experience surgical delays or extended surgical times during procedures. In such cases, patients could develop transient corneal edema—temporary swelling of the cornea.
Healthcare providers should verify lot numbers against the FDA recall list and contact Johnson & Johnson Surgical Vision, Inc. for replacement instructions and guidance on handling affected inventory.
The recalled product
- Product
- VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- Affected units
- 148,941
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)
- 60302489
- 60302939
- 60302941
- 60302953
- 60302954
- 60304170
- 60304175
- 60304176
- 60305660
- 60305661
- 60305662
- 60305665
- 60306934
- 60306935
- 60306936
- 60306940
- 60306942
- 60308193
- 60309850
- 60309844
Distribution
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