Johnson & Johnson Surgical Vision Inc recalls 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 date

December 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0867-2020

FDA classification

Class II

Brand / firm

Johnson & Johnson Surgical Vision Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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