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.
What this means for you
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.
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