CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
Laseredge Knives Arrow Knife Angled (6/Box) recalled
Bausch & Lomb Inc Irb is recalling Laseredge Knives Arrow Knife Angled (6/Box), distributed nationwide in the US. The recall was initiated on 3 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0889-2018
- FDA event ID
- 76874
- Recalling firm
- Bausch & Lomb Inc Irb, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2017
- FDA classified
- 5 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Mar 2017 | Recall initiated by company | |
| 5 Mar 2018 | Classified by FDA | +367 days |
| 14 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
none
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
43 other products · FDA event 76874This product is part of a recall event; the main page for the event is Laseredge Knives Arrow Knife Angled (6/Box) recalled.
More recalls from Bausch & Lomb Inc Irb
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Laseredge Knife X Trapezoid Angled recalled by Bausch & Lomb Inc Irb | Bausch & Lomb Inc Irb | Other | Nationwide |
| Device | CLASS II | Laseredge Arrow Knife Angled recalled by Bausch & Lomb Inc Irb | Bausch & Lomb Inc Irb | Other | Nationwide |
| Device | CLASS II | Laseredge Knives, Crescent Blade Straight Bevel UP Str (6/Box) recalled | Bausch & Lomb Inc Irb | Sterility | Nationwide |
| Device | CLASS II | Laseredge Knives, Clear Corneal Angled 2.75PAR (6/Box) recalled | Bausch & Lomb Inc Irb | Sterility | Nationwide |
| Device | CLASS II | Laseredge Knives Thin Slit Angled Beveled UP (6/Box)(6/Box) recalled | Bausch & Lomb Inc Irb | Sterility | Nationwide |
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