Lower risk Medical device recall · FDA · Published October 30, 2019

Allergan XEN Gel Stent Recall: Residual Compounds May Cause Eye Irritation

Allergan recalls XEN Gel Stents with specific lot numbers due to potential residual polishing compounds on the injector needle that could cause eye irritation, inflammation, or allergic reactions during glaucoma treatment.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0598-2020Medical device Allergan ›

Lower-risk 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.

Take action

Contact the company

Recalling firmAllergan PLC2525 Dupont Dr · Irvine, CA 92612-1531

✎ GovInfoNow plain-language explainer

Allergan is recalling XEN Gel Stents with certain lot numbers because residual polishing compounds from manufacturing may transfer to the patient's eye during surgery, causing irritation, inflammation, or allergic reactions. This recall affects patients who have received the stent for glaucoma treatment and requires them to contact their doctor for evaluation. Read more at govinfonow.com/recall/66586-allergan-xen-gel-stent-recall-residual-compounds-may-cause-eye.

Source Summary by GovInfoNow · govinfonow.com/recall/66586-allergan-xen-gel-stent-recall-residual-compounds-may-cause-eye · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0598-2020

Cite this page

“Allergan XEN Gel Stent Recall: Residual Compounds May Cause Eye Irritation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66586-allergan-xen-gel-stent-recall-residual-compounds-may-cause-eye. Based on FDA recall #Z-0598-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2020%22&limit=1).

The FDA announced on Oct. 30, 2019, that Allergan PLC is recalling XEN Gel Stent devices due to residual polishing compounds on the injector needle. These compounds may transfer to a patient's eye during surgery, causing irritation or inflammation. The agency classified the recall as Class II.

How to tell if you have it

Brand: Allergan
Product: XEN Gel Stent
Model Number (US): REF 5513-001
UPC: 10888628032439
Model Number (Global): REF 5507-001
Model Number (Australia): REF 5517-001
US Lot Codes: 61650, 61657, 61779, 61780, 61825, 61883, 61884, 61906, 61911, 62578, 62608, 62703, 62812, 62874, 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, 62890
Distribution: Worldwide

The hazard

Residual polishing compounds from the needle sleeve manufacturing process may remain on the injector needle. According to the FDA record, these compounds could transfer to the patient's eye during the procedure, possibly resulting in irritation, inflammation, local allergic reaction or hypersensitivity, iritis, uveitis/sterile endophthalmitis, or an intraocular foreign body.

Context

GovInfoNow's records show Allergan, PLC. has 7 other recalls on record since May 24, 2018. Other recent recalls of similar products include Allergan Refresh Relieva Eye Drops (Dec. 30, 2020), Allergan REFRESH Contact Lens Comfort Drops (Dec. 29, 2020), and Allergan Skin Medica Acne Lotion (July 6, 2020). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures (June 24, 2026) and Covidien V-Loc 90 Wound Closure Device (June 24, 2026).

How to tell if you have this one

Check the lot code on the XEN Gel Stent packaging. US lot codes include 61650, 61657, 61779, 61780, 61825, 61883, 61884, 61906, 61911, 62578, 62608, 62703, 62812, 62874, and 62941. Other countries have different lot codes.

Brand
Allergan
Product
Allergan PLC recalls XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Identify the lot code on the XEN Gel Stent packaging to see if it matches the recalled lot numbers listed in the recall notice.
Contact Your Doctor
If you have the recalled stent, contact your eye doctor to discuss potential risks and next steps for evaluation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

Oct 30, 2019Firm started the recall
Dec 4, 2019FDA classified it Class II
Dec 11, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66586-allergan-xen-gel-stent-recall-residual-compounds-may-cause-eye">Allergan XEN Gel Stent Recall: Residual Compounds May Cause Eye Irritation (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0598-2020 (October 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0598-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.