23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments
FDA device recall Z-1693-2016 · posted 2016-05-18 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- The product has potential to leak beyond their design specification.
- Action taken
- The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NGY
- Quantity affected
- 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,
- Date initiated
- 2015-08-11
- Date posted
- 2016-05-18
- Date terminated
- 2017-04-20
- Location
- Fort Worth, TX
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