Recall Z-1066-2019 · HMX Cannula, Ophthalmic

Beaver Visitec

BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

Date	Nov 30, 2018
Status	Terminated
Reason	Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
Root cause	Process control
Action	On 11/30/18, the firm sent an "Urgent: Medical Device Recall" letter dated 11/30/2018 to its customers advising them of the product issue. The letter described the product, problem and actions to be taken. Customers were advised to take the following actions: 1. Immediately examine your inventory and quarantine product from the lots subject to recall. If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may be supported by including a copy of
Quantity	3430 units
Distribution	Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.