Allergan PLC: 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.

Recall number

Z-0598-2020

Recalling firm

Allergan PLC

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.

Status

Open, Classified

Initiated

2019-10-30

Posted

not on file

Terminated

not on file

Reason

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.

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

["K161457"]

PMA numbers

not on file

Product code

KYF

Firm FEI

2011068

Firm city

Irvine

Firm state

CA

Firm country

not on file

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

Copy