FDA Device recall Z-0867-2020
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
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of 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 by Johnson And Johnson Surgical Vision, citing ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0867-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-03 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Johnson And Johnson Surgical Vision |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Model: 10-2400-14, Lots: UE31164, UE31214, UE31440, UE31478, UE31521, UE31560. Model: 10-2705-14, Lots: UE31098, UE3…Model: 10-2400-14, Lots: UE31164, UE31214, UE31440, UE31478, UE31521, UE31560. Model: 10-2705-14, Lots: UE31098, UE31204, UE31283, UE31306, UE31364, UE31409, UE31467, UE31476, UE31507, UE31519, UE31588, UE31408, UE31439, UE31559, UE31587. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0867-2020%22
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