Device recall

Z-0865-2018: LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE…

FDA device recall · Class II · Bausch & Lomb Inc Irb

Key facts

Recall number (Z-number) Z-0865-2018
Recall event 76874
Product LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, 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.
Product code HNN
Recalling firm Bausch & Lomb Inc Irb
Recall class Class II
Status Terminated
Termination date Jun 25, 2018
FEI number 1317628

At a glance

  • None Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)