[Recalled] LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, 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. |
|---|---|
| Brand / manufacturer | Bausch & Lomb Inc Irb |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0891-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 March 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Bausch & Lomb Inc Irb
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.