CLASS II ONGOING Device recall · Reported 11 Dec 2019 · FDA Enforcement Report
XEN Gel Stent recalled by Allergan
Allergan is recalling XEN Gel Stent, distributed nationwide in the US. The recall was initiated on 30 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0598-2020
- FDA event ID
- 84220
- Recalling firm
- Allergan, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2019
- FDA classified
- 4 Dec 2019
- Reported
- 11 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 30 Oct 2019 | Recall initiated by company | |
| 4 Dec 2019 | Classified by FDA | +35 days |
| 11 Dec 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Allergan
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Refresh Contacts¿ Contact Lens Comfort Drops Sterile recalled | Allergan | Other | MO |
| Drug | CLASS II | Refresh Relieva PF Preservative-Free Lubricant Eye Drops Sterile recalledRefresh Relieva Preservative Free | Allergan | Other | Nationwide |
| Drug | CLASS III | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) recalled | Allergan | Potency & Assay | Nationwide |
| Drug | CLASS III | Skin Medica Acne System, Contains: Purifying Foaming Wash recalled | Allergan | Potency & Assay | Nationwide |
| Device | CLASS I | Ritz Princess, Biocell, Intrashiel recalled by Allergan | Allergan | Foreign Material | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |