Recall Z-0778-2018 ยท HQC Unit, Phacofragmentation
Alcon Research, LTD.
Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
| Date | Jan 12, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 300 units |
| Distribution | Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101285 | CONSTELLATION VISION SYSTEM Alcon Manufacturing, Ltd., Nov 12, 2010 |