Johnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices
Johnson & Johnson is recalling Healon GV PRO ophthalmic viscosurgical devices because they may be difficult to remove from the eye, potentially causing increased pressure or equipment clogging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (increased intraocular pressure and ocular injury) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products.
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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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