MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for CONSTELLATION, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752450 manufactured by Alcon Laboratories, Inc..
[145775159]
Vitrector cutter would not cut. A new pack had to be opened to complete the procedure. Product had patient contact but no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8631151 |
| MDR Report Key | 8631151 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-03-20 |
| Report Date | 2019-05-06 |
| Date Reported to FDA | 2019-05-06 |
| Date Reported to Mfgr | 2019-05-22 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | CONSTELLATION, EDGE PLUS, TOTAL PLUS, ULTRAVIT |
| Generic Name | VITRECTOMY, INSTRUMENT CUTTER |
| Product Code | MLZ |
| Date Received | 2019-05-22 |
| Model Number | 8065752450 |
| Catalog Number | 8065752450 |
| Lot Number | 2208022H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |