Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

U.S. FDA — Device Enforcement · United States · 2015-08-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1693-2016
Date of alert: 2015-08-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research, Ltd.
Product category: device
Product type: Devices

Reported risk: The product has potential to leak beyond their design specification.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

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