The Recall Desk
ModerateFDA (Devices)·Z-0779-2018·Announced 2018-03-07

Alcon Recalls 25+ TOTALPLUS Vitrectomy Pak Due to Probe Mismatch

Alcon is recalling specific lots of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a component mismatch (23GA vs 25GA probe) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Alcon Research, LTD. is conducting a voluntary recall of the 25+ TOTALPLUS Vitrectomy Pak, a component of the Custom Pak used for core vitrectomy procedures. The recall affects 52 units from lots 507492, 507664, and 507539, as well as lot 2060953H. These products are distributed worldwide, including in Argentina, Australia, France, Italy, Mexico, Poland, Spain, Sweden, Russia, South Korea, and Ukraine.

The recall is due to a potential error where a 23GA ULTRAVIT probe may have been included in the 25+ TOTALPLUS Vitrectomy Pak instead of the correct 25+ ULTRAVIT probe. This mismatch could affect the performance of the vitrectomy procedure.

Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these products. Alcon is the recalling firm and is managing the distribution of the recall.

The recalled product

Product
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.
Manufacturer
Alcon Research, LTD.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
52

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot 507492
  • 507664
  • 507539

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Alcon Research, LTD.

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Same hazard · component mismatch

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