Reported May 25, 2016 · Terminated
Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments…
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. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
- Lot codes and dates
- Lot Numbers
15011624X15013312X15013313X15014272X15014273X15015769X15016782X15016783X15016784X15018549X15018550X15018554X15018602X15018603X15018606X15018888X15018890X15020828X15020830X15021333X15021337X15022350X15022414X15022416X15025385X15025395X15027298X15027819X15027820X15027834X15027843X15028267X15028268X15031226X15031229X15031231X15031232X15032112X15034244X15034779X
- Lot Numbers
- Amount recalled
- 83,448 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The product has potential to leak beyond their design specification.
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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