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

Recall Z-0778-2018 — Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

U.S. FDA — Device Enforcement · United States · 2018-01-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0778-2018
Date of alert: 2018-01-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research, LTD.
Product category: device
Product type: Devices

Reported risk: Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.

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-0778-2018 — Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

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