Recall Z-0778-2018
Alcon Research, LTD. · initiated January 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Codes / lots: 2060953H
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.
FDA-determined cause: Employee error
Action taken
Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.
Details
- Recall number
- Z-0778-2018
- Initiated
- January 12, 2018
- Terminated
- February 4, 2022
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 300 units
- Distribution
- Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
- Recalling firm
- Alcon Research, LTD., Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0779-2018 Class II | Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.)…Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS… | 01/12/2018Terminated |