Alcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion
Alcon is voluntarily recalling 300 units 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: This is a voluntary precautionary recall for a potential component mismatch (23GA vs 25GA probe) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Alcon Research, LTD. is conducting a voluntary medical device recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak. The recall involves 300 units that were distributed worldwide to Argentina, Australia, France, Italy, Mexico, Poland, Spain, Sweden, Russia, South Korea, and Ukraine.
The recall is being issued because there is a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak instead of the correct 25+ ULTRAVIT probe. The product includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Healthcare providers and facilities should check their inventory for lot 2060953H and stop using these kits if the incorrect probe is identified. Alcon is the recalling firm for this Class II recall.
The recalled product
- Product
- Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
- Manufacturer
- Alcon Research, LTD.
- Hazard
- Affected units
- 300
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 (1)
- 2060953H
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.
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