Alcon Recalls LAUREATE World Phaco System Due to Missing Instructions
Alcon Research is recalling 8,646 units of the LAUREATE World Phaco System because steps 16-25 are missing from the Directions for Use.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (missing steps in instructions) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation-only problems.
Plain-English summary
Alcon Research, Ltd. is recalling 8,646 units of the LAUREATE World Phaco System. The recall is due to a documentation error where steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU).
The affected units are identified by specific lot numbers, including 1658863H, 1805033H, and 1805034H. The product was distributed to Burundi, China, Iran, South Korea, Taiwan, Thailand, and the USA. The source notes that the recalled product is not sold in the USA or its territories, but donated units are in use by a reduced number of USA clients for Medical Missions outside the country.
No specific instructions for consumers are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- LAUREATE World Phaco System
- Manufacturer
- Alcon Research, Ltd.
- Hazard
- Affected units
- 8,646
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 (11)
- Lot Numbers: 1658863H
- 1805033H
- 1805034H
- 1817516H
- 1817517H
- 1826141H
- 1826142H
- 1857622H
- 1857623H
- 1868399H
- 1868400H
Distribution
Distribution scope not specified by the agency.
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