Reported Aug 23, 2023 · Ongoing
Alcon Custom Pak
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, LTD. · 714 Columbia Ave · Sinking Spring, PA · 19608-1405
Is this the product you have?
- Alcon Custom Pak
- Lot codes and dates
3,117 of 3,117 codes
Catalog No. Catalog #0007-670091-690210-700302-820349-780365-750437-380680-740693-660781-630815-680880-410888-690900-280938-600956-690995-8210008-1610014-6310014-6410019-1510027-1210066-1910101-1610101-1710101-1810101-2010166-1610214-1710214-1910222-2110222-2210223-1610223-1710223-1810264-1510275-1710308-1110342-1710356-1510421-2810477-2010482-1510557-1110557-1210558-1110558-1210568-1310572-1910575-1710594-1410632-2010638-2710731-2010735-2110772-3410782-2810804-1710825-17
- Amount recalled
- 1,682,351 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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