Recall Z-0875-2018— Bausch & Lomb Inc Irb
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Inc Irb, initiated 2017-03-03, terminated 2018-06-25. FDA's recall record names no specific 510(k) clearance for this event. Product: LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, 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.. Reason: 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..
- Recalling firm
- Bausch & Lomb Inc Irb
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-03
- Terminated
- 2018-06-25
- Firm location
- Rochester, NY, United States
Product description
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.