Reported Feb 5, 2020 · Terminated
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
Johnson & Johnson Surgical Vision Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision Inc · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933
Is this the product you have?
Healon GV PRO 0.85 mLModel (U.S.): 10-2400-14Model (O.U.S.): 10-2705-1410-2715-1410-2725-14and 10-2755-14
- Lot codes and dates
- Model10-2400-14
- Lots
UE31164UE31214UE31440UE31478UE31521UE31560
- Model10-2705-14
- Lots
UE31098UE31204UE31283UE31306UE31364UE31409UE31467UE31476UE31507UE31519UE31588UE31408UE31439UE31559UE31587
- Amount recalled
- N/A
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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