Class 2 Device Recall BVI Visitec Soft Tip Cannula

• Date Initiated by Firm: November 30, 2018
• Create Date: March 27, 2019
• Recall Status: Terminated on May 01, 2020
• Recall Number: Z-1066-2019
• Recall Event ID: 81757
• Product Classification: Cannula, ophthalmic - Product Code HMX
• Product: 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).
• Code Information: Lots 60047S4, 60060S9, 600623S
• FEI Number: 1211998
• Recalling Firm/ Manufacturer: Beaver Visitec; 500 Totten Pond Rd; 10 City Point; Waltham MA 02451-1916
• For Additional Information Contact: Genci Omari; 866-906-8080
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 this recall notification letter. Your assistance is appreciated and necessary to prevent patient harm. 2. Complete and return the enclosed Product Recall Notice Response & Return Form IMMEDIATELY as evidence of the product being returned and we will credit your account OR complete the response form even if you do not have product to return and Fax 866-906-4304 or email a copy to Claims_US@bvimedical.co. Please include a copy of the completed Response & Return Form with your shipment in Step 3 below. 3. Return ALL quarantined product from the affected lots to our company utilizing the Return Merchandise label that is included with this letter. You may use the prepaid BVI FedEx number for your return. If you have any specific product replacement questions you may contact the Customer Service Team at: Claims_US@bvimedical.com or call 866-906-8080 from 8:00am to 6:00pm EST (Monday Through Friday). If you have any further questions, contact the Manager, Regulatory Affairs at Phone: 866-906-8080 or 781-906-6925.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.