Alcon Laboratories Ireland Ltd.
FDA adverse event reports naming Alcon Laboratories Ireland Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ALCON LABORATORIES IRELAND LTD..
- Total reports
- 8,945
- Deaths
- 0
- Injuries
- 2,940
- Malfunctions
- 5,979
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- TerminatedUnder Investigation by firm
Alcon Clareon IOL with AutonoMe Delivery System
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
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