Reported Dec 11, 2019 · Ongoing
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global…
Allergan PLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergan PLC · 2525 Dupont Dr · Irvine, CA · 92612-1531
Is this the product you have?
- XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439
- Other Model Numbers5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment
- Lot codes and dates
- All Lots within ExpiryUS
- Lot codes
6165061657617796178061825618836188461906619116257862608627036281262874
- and 62941 OUS Lot codes
615666158061626616426168561846618476195561966620086230162053620666210862130622636229762318623806253862636626786268362719627456274962769 and 62890
- Amount recalled
- 145,711 Glaucoma Treatment Systems
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Allergan PLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.