Recall Z-1693-2016— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2015-08-11, terminated 2017-04-20. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-11
- Terminated
- 2017-04-20
- Firm location
- Fort Worth, TX, United States
Product description
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 for recall
The product has potential to leak beyond their design specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.