Recall Z-1693-2016
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
23G and 25G Constellation Totalplus Paks 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: 1711482H 1711485H 1714709H 1714711H 1714712H 1714713H 1714715H 1714716H 1714717H 1714736H 1714737H 1714738H 1714739H 1717871H 1717872H 1717874H 1717895H 1717896H 1717902H 1726095H 1726102H 1726103H 1726104H 1726105H 1726106H 1726107H 1726118H 1726119H 1726120H 1726121H 1726122H 1731592H 1731595H 1731929H 1731930H 1731931H 1731932H 1731933H 1734476H 1734478H 1734479H 1734480H 1734481H 1734546H 1734547H 1734548H 1734549H 1734550H 1734551H 1734552H 1734559H 1734560H 1734561H 1734562H 1734563H 1734564H 1734565H 1734566H 1734567H 1734568H 1734569H 1734570H 1734571H 1734572H 1734573H 1734574H 1735125H 1735126H 1735127H 1735128H 1735129H 1735130H 1735131H 1735132H 1746173H 1746197H 1746198H 1746199H 1746200H 1746201H 1747011H 1747012H 1747013H 1747014H 1747015H 1749215H 1749216H 1749217H 1749218H 1749219H 1749220H 1749221H 1751293H 1753301H 1753302H 1753303H 1753323H 1753324H 1753325H 1753326H 1753327H 1753328H 1753329H 1753339H 1753342H 1753346H 1753347H 1753348H 1753360H 1753361H 1753362H 1753363H 1756285H 1756286H 1759094H 1759095H 1759096H 1759097H 1759098H 1759099H 1759100H 1759101H 1759171H 1759172H 1759173H 1759174H 1759175H 1759176H 1759182H 1759183H 1759185H…
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-1693-2016
- Initiated
- August 11, 2015
- Posted by FDA
- May 18, 2016
- Terminated
- April 20, 2017
- Product code
- NGY – Cannula, Trocar, Ophthalmic
- Quantity
- 225,000 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-1692-2016 Class II | Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the…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 |