Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Recalled by Alcon Research, LTD. Due to Alcon is conducting this Voluntary Medical Device Recall...

Date: January 12, 2018
Company: Alcon Research, LTD.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, LTD. directly.

Affected Products

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.

Quantity: 52 units

Why Was This Recalled?

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.

Where Was This Sold?

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

About Alcon Research, LTD.

Alcon Research, LTD. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report