Johnson & Johnson Surgical Vision, Inc. 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2247-2023
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) Recall
Issued August 9, 2023 · Johnson & Johnson Surgical Vision, Inc.
In August 2023, Johnson & Johnson Surgical Vision, Inc. recalled the VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF), a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Johnson & Johnson Surgical Vision, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Johnson & Johnson Surgical Vision, Inc.
- Category
- Health
- Recall date
- August 9, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of NC, OH, NY, IN, FL, TN, CA, PA, AZ, AL, TX, WA, WV, MS, GA, UT, KY, IA, MO
- Recall number
- FDA-Z-2247-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Johnson & Johnson Surgical Vision, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.