Class 2 Device Recall Xen Glaucoma Treatment System

• Date Initiated by Firm: October 30, 2019
• Create Date: December 04, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0598-2020
• Recall Event ID: 84220
• 510(K)Number: K161457
• Product Classification: Implant, eye valve - Product Code KYF
• Product: XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
• Code Information: All Lots within Expiry: US Lot codes: 61650, 61657, 61779, 61780, 61825, 61883, 61884, 61906, 61911, 62578, 62608, 62703, 62812, 62874 and 62941 OUS Lot codes: 61566, 61580, 61626, 61642, 61685, 61846, 61847, 61955, 61966, 62008, 62301, 62053, 62066, 62108, 62130, 62263, 62297, 62318, 62380, 62538, 62636, 62678, 62683, 62719, 62745, 62749, 62769 and 62890
• Recalling Firm/ Manufacturer: Allergan PLC; 2525 Dupont Dr; Irvine CA 92612-1531
• For Additional Information Contact: Nicole Katz; 862-261-7084
• Manufacturer Reason for Recall: Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.
• FDA Determined Cause: Vendor change control
• Action: On October 30, 2019, Allergan mailed a "Urgent Device Recall" letter to consignees via FedEx overnight. In addition to informing the customer about the recall, the letter requested consignees take the following actions: 1. If you have inventory of the recalled products, quarantine product to prevent its use. 2. Conduct a physical count of the affected products in your possession and record the count on the enclosed Business Reply Form (BRF). 3. When returning the recalled product, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton. Return the recalled product and completed BRF to: Inmar Rx Solutions, Inc. 4332 Empire Rd. Fort Worth, TX 76155 4. If you have no recall product to return, please complete the BRF and return to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Reply Form even if no recalled product is present. 5. Please Do Not return any products that are not the subject of this recall. 6. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions at 1-877-756-2970, 9:00am - 5:00pm EST. 7. For Adverse Events/Product Complaints Contact Allergan at: 1-800-624-4261, 9am  6pm EST 8. Medical Information: 1-800-678-1605 option #2, 8:30 am  5:00 pm EST or IR-Medcom@allergan.com 9. FDA contact information for reporting adverse events: Online at www.fda.gov/medwatch/report.htm or call FDA at 1-800-FDA-1088
• Quantity in Commerce: 145,711 Glaucoma Treatment Systems
• Distribution: Worldwide distribution. US nationwide, countries of AE, AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, KR, LT, MT, MU, MX, MY, NA, NL, NO, NZ, PH, PL, PT, RO, RS, SA, SE, SG, SI,SK, SM,TH,TR, TW, VE, and ZA.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KYF and Original Applicant = Allergan, Inc.