Recall Z-0867-2020— Johnson & Johnson Surgical Vision Inc

Name: FDA recall Z-0867-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-03

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Surgical Vision Inc, initiated 2019-12-03, terminated 2021-04-28. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..

Recalling firm: Johnson & Johnson Surgical Vision Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-03
Terminated: 2021-04-28
Firm location: Santa Ana, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.