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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Johnson & Johnson Surgical Vision Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Johnson & Johnson Surgical Vision Inc is recalling 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, due to Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026