Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items… — Class II medical device recall Z-0778-2018
Terminated recall by Alcon Research, LTD., reported 2018-03-07. Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vi
| Recall number | Z-0778-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LTD., Houston, TX, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-02-28 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2022-02-04 |
| Countries outside the US | AR, AU, ES, FR, IT, KR, MX, PL, RU, SE, UA |
| Quantity | 300 units |
Product
Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0778-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.