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.
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.
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.
Residual polishing compounds used in the needle sleeve manufacturing process may be present on the injector needle. If these compounds transfer to the patient's eye during surgery, they could cause irritation, inflammation, allergic reactions, or infections like uveitis or sterile endophthalmitis.
Patients who have received the XEN Gel Stent for glaucoma treatment with the specific lot numbers listed in the recall are most at risk. The recall applies to those who have been prescribed the stent by a doctor.
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.
Identify the lot code on the XEN Gel Stent packaging to see if it matches the recalled lot numbers listed in the recall notice.
If you have the recalled stent, contact your eye doctor to discuss potential risks and next steps for evaluation.
The XEN Gel Stent is an implant used for glaucoma treatment.
US lot codes: 61650, 61657, 61779, 61780, 61825, 61883, 61884, 61906, 61911, 62578, 62608, 62703, 62812, 62874, and 62941. Other countries have different lot codes.
No, the recall does not require immediate discontinuation. Patients should contact their doctor for evaluation if they have the recalled stent.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-0598-2020 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-0598-2020 from Allergan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
