MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-23 for 25 TOTOALPLUS VITRECTOMY PACK 8065751617 manufactured by Alcon.
[71014743]
Retained piece of material in patient's eye from a portion of the 25g totalplus vitrectomy pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068664 |
| MDR Report Key | 6435841 |
| Date Received | 2017-03-23 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-03-07 |
| Date Added to Maude | 2017-03-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 25 TOTOALPLUS VITRECTOMY PACK |
| Generic Name | 25 TOTOALPLUS VITRECTOMY PACK |
| Product Code | MLZ |
| Date Received | 2017-03-23 |
| Model Number | 8065751617 |
| Lot Number | 19804262H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-23 |