Alcon Research, LTD.: Medical Device Recall in 2018 - (Recall #: Z-0779-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 12, 2018

Date Posted: March 7, 2018

Recall Number: Z-0779-2018

Event ID: 79226

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.

Status: Terminated

Product Quantity: 52 units

Code Information:

Lot 507492, 507664, 507539

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated