Abbott Healon EndoCoat Ophthalmic Device Recalled for Finger Grip Defect
Abbott Medical Optics is recalling Healon EndoCoat ophthalmic devices because the finger grip can dislodge, potentially causing eye trauma during surgery.
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 involves a risk-of-harm product where injury (potential eye trauma) has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Abbott Medical Optics Inc (AMO) is recalling the Abbott Healon EndoCoat Ophthalmic Viscosurgical Device and the Abbott Healon Duet Dual Pack. The recall was initiated after the company received complaints that the finger grip on the syringe plunger dislodged during use.
The defect poses a risk to patients because if the finger grip dislodges while the surgeon is depressing the plunger, the surgeon's hand may unintentionally move the cannula further than intended. This movement can result in potential trauma to the eye.
The recall affects 484,881 units distributed nationwide in the U.S. and Puerto Rico, and 483,984 units distributed internationally. Affected products include specific part numbers for the Healon EndoCoat Device and the Healon Duet Dual Pack. Healthcare providers should stop using these devices and contact Abbott Medical Optics for instructions on how to return or dispose of the product.
The recalled product
- Product
- Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of…
- Manufacturer
- Abbott Medical Optics Inc (AMO)
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 (2)
- 10220011
- and 10220012) Healon EndoCoat Device identification: For Healon EndoCoat
Distribution
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