MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-09-22 for N/A 8065740837 manufactured by Ascent Healthcare Solutions.
[1153033]
During the procedure, the tip of the phaco broke off. At the time, the tip had no fluid under pressure and was lying on top of the lense, and the doctor was able to retrieve the broken tip without issue or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8383643]
The device was not returned to ascent healthcare solutions for evaluation, and the device was not saved, so pictures of the device were not available. The packaging or labeling was not returned either. Since the device was not returned, the complaint could not be confirmed, a device evaluation could not be performed, and a root cause could not be determined. The device history record for the returned device indicates that the device passed all applicable inspections and tests prior to release. Due to the infrequency of this type of event, no trend analysis is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2009-00004 |
| MDR Report Key | 1479554 |
| Report Source | 05,06,07 |
| Date Received | 2009-09-22 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-08-25 |
| Date Mfgr Received | 2009-08-30 |
| Device Manufacturer Date | 2009-04-10 |
| Date Added to Maude | 2009-09-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Street | 10232 SOUTH 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NKX |
| Product Code | NKX |
| Date Received | 2009-09-22 |
| Model Number | 8065740837 |
| Catalog Number | 8065740837 |
| Lot Number | 825788SH |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 SOUTH 51ST STREET PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-22 |