FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc Irb: Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
- Recall number
- Z-2366-2019
- Recalling firm
- Bausch & Lomb Inc Irb
- Product
- Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
- Status
- Terminated
- Initiated
- 2016-07-11
- Posted
- not on file
- Terminated
- 2019-08-30
- Reason
- Possible dull knife edge
- 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
- 165 packs/6 blades (990 individiual blades)
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Number: MAXZ170 Expiry Date: 01/28/2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28