Johnson & Johnson Surgical Vision recalls Healon GV PRO 0.85mL devices with specific models and lots due to difficulty removing from the eye, potentially causing increased pressure or ocular injury.
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.
Johnson & Johnson Surgical Vision is recalling Healon GV PRO 0.85 mL ophthalmic viscosurgical devices with certain model numbers and lots. These devices may be difficult to remove from the eye, leading to higher eye pressure or clogging of surgical equipment, which could cause delays or injury during eye surgery.
The device may not come out easily from the eye after surgery, causing higher pressure inside the eye. This could require extra medical steps or even lead to clogging of the surgical equipment, delaying the procedure or causing eye injury.
Surgical patients and medical professionals using the recalled Healon GV PRO 0.85 mL devices for eye procedures. Those with the specific model numbers and lots listed are most at risk.
Check the model number on the device: U.S. models include 10-2400-14, O.U.S. models include 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14. Also check the lot numbers listed in the recall notice for affected devices.
Identify the model number and lot number on the device to see if it matches the recalled items listed in the notice.
The Healon GV PRO 0.85 mL devices may be difficult to remove from the eye, leading to increased postoperative intraocular pressure or clogging of surgical equipment, which could cause delays or injury.
The recall notice does not specify a remedy, so check the model and lot numbers to see if your device is affected. If it is, contact the manufacturer for further instructions.
Yes, the device may cause increased eye pressure or clog surgical equipment, potentially leading to delays in surgery or eye injury.
We’ve drafted a message you can send Johnson & Johnson Surgical Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0867-2020 — Johnson & Johnson Surgical Vision Johnson & Johnson Surgical Vision Hello, I own a Johnson & Johnson Surgical Vision that is covered by recall Z-0867-2020 from Johnson & Johnson Surgical Vision. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
