Z-0867-2020Class II

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...

Name: 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...
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2019-12-03
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2019-12-03 / Terminated / root cause: labeling and UDI

FDA source

Johnson & Johnson Surgical Vision Inc began a 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 on 2019-12-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0867-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-03
Posted: 2020-01-27
Terminated: 2021-04-28
Recalling firm: Advanced Medical Optics, Inc.
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
Product code: LZP Aid, Surgical, Viscoelastic
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Customers were asked to immediately take the following actions: 1. Compare your inventory against the affected product list. 2. Discontinue using and remove from your inventory all affected lots. 3. Even if you have no inventory, please complete the Customer Reply Form. If you have inventory of any of the affected OVDs products, please complete the Customer Reply Form, noting the lot numbers of the OVDs, and use the shipping label provided to return the product. Returned product will NOT require refrigerated shipping. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. Customers may call 1-877-266-4543 Option 2 if they have additional questions or want to report complaints or adverse events.
Distribution: U.S.: CA, PA, NJ, GA, IL, MO, CO, TX, FL, AK, NY, HI, UT, LA, OH, IN, MA, NC, AZ, MI, NH, AL, TN, WA, MD, OR, VA, MS, MN, KY, AR, NV, WI, WV, SC, DE, ME, CT, ID, NM, VT, IA, OK, MT, NE, DC. OUS: DE, GB, DK, IT, NL, TR, AT, CH, FR, GR, ES, PT, FO, BE, GP, ZA, IE, HR, HU, IS, NO, SE, FI
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0867-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0867-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-27

Product code LZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)