Allergan Recalls XEN Gel Stent Due to Residual Polishing Compounds
Allergan is recalling XEN Gel Stent implants because residual polishing compounds on the injector needle may transfer to the patient's eye, causing irritation or inflammation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where potential injuries such as inflammation and foreign bodies are described, but no specific reported illnesses or injuries are stated in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Allergan PLC is recalling XEN Gel Stent implants, which are used for glaucoma treatment. The recall involves 145,711 Glaucoma Treatment Systems distributed worldwide, including across the United States and numerous international locations.
The recall is due to the potential presence of residual polishing compounds on the injector needle, which are used in the manufacturing process. These compounds could transfer to the patient's eye during the procedure, potentially resulting in irritation, inflammation, local allergic reactions, iritis, uveitis, sterile endophthalmitis, or an intraocular foreign body.
Patients who have received these implants should contact their healthcare provider for guidance. The recall covers specific US and international lot codes listed in the official notice.
The recalled product
- 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.
- Manufacturer
- Allergan PLC
- Affected units
- 145,711
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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