Johnson & Johnson Surgical Vision Inc: 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

Recall number

Z-0867-2020

Recalling firm

Johnson & Johnson Surgical Vision 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

Status

Terminated

Initiated

2019-12-03

Posted

2020-01-27

Terminated

2021-04-28

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.

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.

Quantity

not on file

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

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P810031"]

Product code

LZP

Firm FEI

3003843509

Firm city

Santa Ana

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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