Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage
Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (leakage) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or functional issues without reported harm.
Plain-English summary
Alcon Research, Ltd. is recalling 6,597 INFINITI Ultrasound Packs. These are ophthalmic microsurgical systems used for phacoemulsification and the removal of cataracts. The recall covers specific catalog numbers and lot numbers distributed nationwide.
The recall was initiated after the company received complaints regarding leakage from the tubing near the white luer of the irrigation line. This defect could potentially affect the performance of the surgical system during use.
Healthcare providers and facilities that have these specific packs should stop using them and contact Alcon Research for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
- Manufacturer
- Alcon Research, Ltd.
- Hazard
- Affected units
- 6,597
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)
- Lot numbers: 1623139H
- 1623140H
- 1623138H
- 1623141H
- 1623765H
- 1623148H
- 1623766H
- 1623767H
- 1623768H
- 1623142H
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Alcon Research, Ltd.
See all →- SevereAlcon Constellation Procedure Pak recalled due to plastic debris risk
FDA (Devices) · 2023-08-23
- SeverePhaco Standalone Tips Recalled Due to Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereAlcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereLegion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris
FDA (Devices) · 2023-08-23
- HighCenturion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris
FDA (Devices) · 2023-08-23
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighAlcon Recalls INFINITI Vision System Ultrasound FMS Due to Tubing Debris
FDA (Devices) · 2014-12-10
- HighIntegra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage
FDA (Devices) · 2014-12-10
- HighMicrotek Medical Recalls Laparoscopic Tubing Sets Due to Unlabeled Latex Packaging
FDA (Devices) · 2015-04-08
- HighICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
FDA (Devices) · 2019-10-23
- HighICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
FDA (Devices) · 2019-10-23
- SevereICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
FDA (Devices) · 2019-10-23