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Recall Observatory FDA recall evidence

Device product

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

Z-0778-2018

January 12, 2018

Class II

Product summary

Firm
Alcon Research, LTD.
Event
Event 79226
Status
Terminated
Classification
Class II
Quantity
300 units
Official record key
device-enforcement:Z-0778-2018

Official wording

Reason: 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.

Code information: 2060953H

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.