Healon GV PRO 0 — Class II medical device recall Z-0867-2020
Terminated recall by Johnson & Johnson Surgical Vision Inc, reported 2020-02-05, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative in
| Recall number | Z-0867-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision Inc, Santa Ana, CA, United States |
| Recall initiated | 2019-12-03 |
| Classified | 2020-01-27 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2021-04-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV |
| Lot numbers | UE31098, UE31164, UE31204, UE31214, UE31283, UE31306, UE31364, UE31408, UE31409, UE31439, UE31440, UE31467, UE31476, UE31478, UE31507, UE31519, UE31521, UE31559, UE31560, UE31587, UE31588 |
| Model numbers | 10-2400-14, 10-2705-14, 10-2715-14, 10-2725-14, 10-2755-14, UE31098, UE31164, UE31204, UE31214, UE31283, UE31306, UE31364, UE31408, UE31409, UE31439, UE31440, UE31467, UE31476, UE31478, UE31507, UE31519, UE31521, UE31559, UE31560, UE31587 and 1 more |
Product
Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
Reason for recall
Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0867-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.