Use caution Medical device recall · FDA · Published December 3, 2019

Johnson & Johnson Surgical Vision Healon GV PRO 0.85mL Recall: Difficulty Removing

Johnson & Johnson Surgical Vision recalls Healon GV PRO 0.85mL devices with specific models and lots due to difficulty removing from the eye, potentially causing increased pressure or ocular injury.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0867-2020Medical device Johnson & Johnson Surgical Vision ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmJohnson & Johnson Surgical Vision Inc1700 E Saint Andrew Pl · Santa Ana, CA 92705-4933

✎ GovInfoNow plain-language explainer

Johnson & Johnson Surgical Vision is recalling Healon GV PRO 0.85 mL ophthalmic viscosurgical devices with certain model numbers and lots. These devices may be difficult to remove from the eye, leading to higher eye pressure or clogging of surgical equipment, which could cause delays or injury during eye surgery. Read more at govinfonow.com/recall/66410-johnson-johnson-surgical-vision-healon-gv-pro-0-85ml-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/66410-johnson-johnson-surgical-vision-healon-gv-pro-0-85ml-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0867-2020

Cite this page

“Johnson & Johnson Surgical Vision Healon GV PRO 0.85mL Recall: Difficulty Removing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66410-johnson-johnson-surgical-vision-healon-gv-pro-0-85ml-recall. Based on FDA recall #Z-0867-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0867-2020%22&limit=1).

The FDA announced on 2019-12-03 that Johnson & Johnson Surgical Vision Inc. is recalling Healon GV PRO ophthalmic viscosurgical devices due to risks of increased intraocular pressure and potential ocular injury, according to the FDA.

How to tell if you have it

Brand: Johnson & Johnson Surgical Vision
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
Lots: UE31164, UE31214, UE31440, UE31478, UE31521, UE31560 (Model 10-2400-14); UE31098, UE31204, UE31283, UE31306, UE31364, UE31409, UE31467, UE31476, UE31507, UE31519, UE31588, UE31408, UE31439, UE31559, UE31587 (Model 10-2705-14)

The hazard

The ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Reports also indicate clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.

Context

GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since 2018-05-09. Other recent recalls of similar products include Johnson & Johnson Surgical Vision Recalls HEALON Products for Corneal Injury Risk (2026-07-31), Johnson & Johnson VISION Recalls Irrigation Sleeves: Risk of Insufficient Flow During Eye Surgery (2024-03-14), and Johnson & Johnson Surgical Vision Recalls TECNIS Toric II IOLs with Angle Issue (2023-12-12).

How to tell if you have this one

Check the model number on the device: U.S. models include 10-2400-14, O.U.S. models include 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14. Also check the lot numbers listed in the recall notice for affected devices.

Brand
Johnson & Johnson Surgical Vision
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model and Lot
Identify the model number and lot number on the device to see if it matches the recalled items listed in the notice.

Where it went and when

Where it was distributed

Distributed in 45 states and D.C..

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Dec 3, 2019Firm started the recall
Jan 27, 2020FDA classified it Class II
Feb 5, 2020Published in FDA’s Enforcement Report
Apr 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Johnson & Johnson Surgical Vision recalls

Link to this recall

<a href="https://govinfonow.com/recall/66410-johnson-johnson-surgical-vision-healon-gv-pro-0-85ml-recall">Johnson &amp; Johnson Surgical Vision Healon GV PRO 0.85mL Recall: Difficulty Removing (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0867-2020 (December 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0867-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.