Recall Z-2252-2021 ยท HQC Unit, Phacofragmentation
Dutch Ophthalmic USA, Inc.
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
| Date | May 21, 2019 |
| Status | Open, Classified |
| Reason | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line |
| Root cause | Under Investigation by firm |
| Action | Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019. |
| Quantity | 16 boxes |
| Distribution | US Nationwide Distribution in the states of AL, CA, CO, FL, MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine wit D.O.R.C. Dutch Ophthalmic Research Center (International), Sep 25, 2019 |