Z-2366-2019Class II

Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599

Name: Z-2366-2019 Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599
Creator: Bausch & Lomb Inc Irb
Published: 2016-07-11
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2016-07-11 / Terminated / root cause: supplier

FDA source

Bausch & Lomb Inc Irb began a recall of Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures on 2016-07-11. FDA classified it as Class II and gives the reason as "Possible dull knife edge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2366-2019
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Posted: 2019-08-24
Terminated: 2019-08-30
Recalling firm: Bausch & Lomb Incorporated
Product: Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
Product code: HNN Knife, Ophthalmic
Reason for recall: Possible dull knife edge
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On July 14, 2016, Baush + Lomb issued Medical Device Voluntary Product Recall notices to customers. Customers were instructed to take the following actions: 1. Please review your inventory and hold all unused boxes 2. Quarantine any unused boxes (full and partial) and take the following steps to return the product to Bausch + Lomb at the recalling firm's expense. 3. Please complete the Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).
Quantity in commerce: 165 packs/6 blades (990 individiual blades)
Distribution: US Nationwide Distribution
Product codes and lots: Lot Number: MAXZ170 Expiry Date: 01/28/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2366-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2365-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23
Z-2366-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)