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
Reported: February 5, 2020 Initiated: December 3, 2019 #Z-0867-2020
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Johnson & Johnson Surgical Vision Inc
- Units Affected
- N/A
- 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
- Location
- Santa Ana, CA
Frequently Asked Questions
What product 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. Recalled by Johnson & Johnson Surgical Vision Inc. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2020. Severity: Moderate. Recall number: Z-0867-2020.
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