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.
Enforcement
- Recall Number
- Z-1692-2016
- Event ID
- 73777
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Alcon Research, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 25, 2016
- Initiation Date
- August 11, 2015
- Classification Date
- May 18, 2016
- Termination Date
- April 20, 2017
- Address
- 6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States
Description
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.
The product has potential to leak beyond their design specification.
Lot Numbers: 15011624X, 15013312X, 15013313X, 15014272X, 15014273X, 15015769X, 15016782X, 15016783X, 15016784X, 15018549X, 15018550X, 15018554X, 15018602X, 15018603X, 15018606X, 15018888X, 15018890X, 15020828X, 15020830X, 15021333X, 15021337X, 15022350X, 15022414X, 15022416X, 15025385X, 15025395X, 15027298X, 15027819X, 15027820X, 15027834X, 15027843X, 15028267X, 15028268X, 15031226X, 15031229X, 15031231X, 15031232X, 15032112X, 15034244X, 15034779X
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83,448 units