Abbott Recalls Healon Medical Device Due to Glass Particle Risk
Abbott Medical Optics is recalling Healon medical devices because certain lots may contain microscopic glass particles from manufacturing damage.
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 (microscopic glass particles) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling specific lots of Healon, a medical device used in ophthalmic procedures. The recall involves 293,867 units distributed in the United States and worldwide, including numerous countries in Europe, Asia, and South America.
The recall was initiated due to a remote possibility that certain solutions in these lots may contain microscopic glass particles. This potential contamination is attributed to damage that occurred at the cylinder neck during the manufacturing process.
Consumers and healthcare providers should check their inventory for the specific part numbers and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to Abbott Medical Optics or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Affected units
- 293,867
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 (10)
- UB32602
- UB32593
- UB32514
- UB32521
- UB32579
- UB32573
- UB32599
- UB32614
- UB32616
- UB32533
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Abbott Medical Optics Inc. (AMO) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Abbott Medical Optics Inc. (AMO)
See all →- LowAbbott AMO Vitrectomy Cutters Recalled for Packaging Error
FDA (Devices) · 2017-05-24
- HighAbbott Recalls Healon V Due to Possible Microscopic Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon GV Due to Possible Microscopic Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon Pro Due to Possible Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon 5 Pro Due to Possible Glass Particles
FDA (Devices) · 2017-05-17
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- SevereUkrop's Bread Pudding Recalled for Metal Fragments
FDA (Food) · 2026-09-09
Similar recalls
- HighAbbott Healon EndoCoat Ophthalmic Device Recalled for Finger Grip Defect
FDA (Devices) · 2014-12-17
- HighJohnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices
FDA (Devices) · 2020-02-05
- HighB. Braun AMO Administration Set Recalled for Manufacturing Defect Causing Leakage
FDA (Devices) · 2023-11-15
- HighBurlington Medical Recalls Half Aprons Due to Potential Radiation Protection Deficiency
FDA (Devices) · 2019-08-07
- ModerateAbbott Recalls Mislabeled AMO Sensar Intraocular Lenses
FDA (Devices) · 2013-03-20
- HighBetaxolol ophthalmic solution recalled for manufacturing process violations
FDA (Drugs) · 2023-01-25