Reported Aug 9, 2023 · Ongoing
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Johnson & Johnson Surgical Vision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision, Inc. · 31 Technology Dr Ste 200 · Irvine, CA · 92618-2302
Is this the product you have?
- VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
- Lot codes and dates
- All lots within their expiration date as of 5/29/2023
- Part Number/UDI-DI/Lot
97 of 97 codes
VRT-AI/05050474700901/602989316030248960302939603029416030295360302954603041706030417560304176603056606030566160305662603056656030693460306935603069366030694060306942603081936030985060309844603098456030985360314642603146766031467760316112603516926037249060372491603741756037494560376930603788406037884260378844604007956040198460413115604131166041311760414191604150776041507860416304604200036042195260425389604263146042631560428217604282166042944260433653604336546043365560435921604359226043592360437988
- Amount recalled
- 148,941
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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