FDAFDA · Food and drugs·Recall number Z-0876-2018
LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Published March 14, 2018 · Recall initiated: March 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bausch & Lomb Inc Irb
- Distributor
- US Nationwide Distribution
- Lot
- none
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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