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 Initiated
- December 3, 2019
- Posted
- January 27, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-0867-2020
- Firm Location
- Santa Ana, CA
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.
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
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.
Root Cause
Labeling False and Misleading
Action Taken
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.