MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for INFINITI VISION SYSTEM TURBOSONIC MICRO TIP 8065750159 manufactured by Alcon Research, Ltd.
[40652882]
Patient Sequence No: 1, Text Type: N, H10
[40652883]
During a cataract extraction surgery, the phaco tip being used on the piece of equipment broke off in the patient's eye. The surgeon was able to retrieve it and it did not cause harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5510000 |
| MDR Report Key | 5510000 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-02-17 |
| Report Date | 2016-03-04 |
| Date Reported to FDA | 2016-03-04 |
| Date Reported to Mfgr | 2016-03-04 |
| Date Added to Maude | 2016-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | INFINITI VISION SYSTEM TURBOSONIC MICRO TIP |
| Generic Name | APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED |
| Product Code | HQR |
| Date Received | 2016-03-18 |
| Model Number | 8065750159 |
| Lot Number | 1429909H |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-18 |