Z-0598-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- October 30, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145,711 Glaucoma Treatment Systems
Product Description
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.
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.
Distribution Pattern
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.
Code Information
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