Recall Z-1692-2016
Alcon Research, Ltd. · initiated August 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
Reason for recall
The product has potential to leak beyond their design specification.
FDA-determined cause: Process control
Action taken
The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
Details
- Recall number
- Z-1692-2016
- Initiated
- August 11, 2015
- Posted by FDA
- May 18, 2016
- Terminated
- April 20, 2017
- Product code
- NGY – Cannula, Trocar, Ophthalmic
- Quantity
- 83,448 units
- Distribution
- United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania…
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1693-2016 Class II | 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |
| Z-1694-2016 Class II | Custom Paks containing 23G and 25G valved trocar cannula provide access into the…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |