Z-0598-2020Class II

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers...

Name: Z-0598-2020 XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers...
Creator: Allergan PLC
Published: 2019-10-30
License: https://open.fda.gov/license/

Allergan / initiated 2019-10-30 / Open, Classified / root cause: supplier

FDA source

Allergan PLC began a recall of 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... on 2019-10-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0598-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-30
Posted: 2019-12-04
Recalling firm: Allergan
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.
Product code: KYF Implant, Eye Valve
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.
Root cause tag: supplier
FDA 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0598-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0598-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-11	2019-12-04

Product code KYF

K161457Class IIXEN Glaucoma Treatment SystemAllergan, Inc. / cleared 2016-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)