# FDA recall Z-0598-2020

> **Allergan PLC** · Class II · device recall initiated 2019-10-30.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-0598-2020
- **Recalling firm:** Allergan PLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-30
- **Report date:** 2019-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0598-2020

## Citation

> AI Analytics. FDA recall Z-0598-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0598-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*