Johnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices

Plain-English summary

Johnson & Johnson Surgical Vision Inc is recalling specific lots of Healon GV PRO 0.85 mL ophthalmic viscosurgical devices. The recall covers U.S. model 10-2400-14 and O.U.S. models 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14. The affected products were distributed to various states in the United States and multiple countries outside the U.S.

The recall was initiated because the device may be difficult to remove from the eye. This difficulty can lead to increased postoperative intraocular pressure, which may require additional medical intervention. Additionally, there are reports of clogging in phacoemulsion equipment tubing, which may delay surgical procedures or result in ocular injury.

Healthcare providers and patients should check their inventory and records for the specific model numbers and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor according to the recall instructions.

The recalled product

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

Manufacturer

Johnson & Johnson Surgical Vision Inc

Category

Medical Device — Ophthalmic

Hazard

• ocular-injury
• increased-intraocular-pressure
• equipment-clogging

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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