medical Class II Updated 2020-02-05

Johnson & Johnson Surgical Vision Inc recalls Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: 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.

View official government recall

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