FDA Device recall Z-1693-2016
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of…
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of… by Alcon Research, citing the product has potential to leak beyond their design specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1693-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-11 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alcon Research |
| Distribution | PR |
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.
Reason
The product has potential to leak beyond their design specification.
Identifiers
| code_info | Lot Numbers: 1711482H 1711485H 1714709H 1714711H 1714712H 1714713H 1714715H 1714716H 1714717H 1714736H 171473…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 1753325 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1693-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.