Alcon Recalls INFINITI Vision System Ultrasound FMS Due to Tubing Debris
Alcon is recalling INFINITI Vision System Ultrasound FMS units because pieces of tubing may be present in the aspiration line.
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 the hazard involves a risk-of-harm product (foreign material in a sterile medical device) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Alcon Research, Ltd. is conducting a recall of the INFINITI Vision System Ultrasound FMS, a sterile, single-use fluid management system. The recall is due to the possible presence of pieces of tubing in the aspiration line.
The affected product is indicated for emulsification, separation, and removal of cataracts, removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The recall covers 147,473 units distributed worldwide, including the United States, Canada, Mexico, and numerous other countries.
Healthcare providers and patients should stop using the affected units and contact Alcon for further instructions. The specific lot numbers and model numbers involved are listed in the official recall documentation.
The recalled product
- Product
- INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268…
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 147,473
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)
- Lot Numbers: 1623755H
- 1623756H
- 1637071H
- 1637072H
- 1637073H
- 1642718H
- 1642719H
- 1642720H
- 1642721H
- 1644878H
- 1647623H
- 1647624H
- 1647625H
- 1647626H
- 1647627H
- 1647628H
- 1647973H
- 1647974H
- 1647975H
- 1647976H
Distribution
Distributed nationwide across the United States.
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