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Terminated

Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

FDA Recall Z-0779-2018 · Posted None

Recalling FirmAlcon Research, LTD.
Recall StatusTerminated
Product CodeHQC
Date Initiated2018-01-12
Date Terminated2022-02-04
Product Quantity52 units

Reason for Recall

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.

Firm Action

Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101285CONSTELLATION VISION SYSTEMAlcon Manufacturing, Ltd. · 2010-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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