Johnson & Johnson Surgical Vision, Inc. 2024-05-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1755-2024
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber … Recall
Issued May 8, 2024 · Johnson & Johnson Surgical Vision, Inc.
In May 2024, Johnson & Johnson Surgical Vision, Inc. recalled the Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
What you should do
- 1 Stop using Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber … 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
- May 8, 2024
- Units affected
- Not reported
- Sold at
- U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OR, PA, SC, TX, VA, WA, and WI.
- Recall number
- FDA-Z-1755-2024
- 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 737th Health recall we've logged in 2024.