MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for SLIT LAMP ADAPTATION 8065-5010-01 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[44350489]
The system was examined and the reported event was not replicated. The system was tested and found to meet product specifications. A review of the customer? S complaint history for the last 24 months did not show any previous complaints of this kind against the system. The associated laser was manufactured on november 6, 2014. Based on qa assessment, the product met specifications at the time of release. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44350490]
A customer reported experiencing less power delivery from the slit lamp before a procedure. There was no patient involvement. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2016-01767 |
| MDR Report Key | 5608302 |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-26 |
| Date Mfgr Received | 2016-04-10 |
| Date Added to Maude | 2016-04-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SLIT LAMP ADAPTATION |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2016-04-26 |
| Model Number | NA |
| Catalog Number | 8065-5010-01 |
| Lot Number | NA |
| ID Number | 2.00_BLD_0045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-26 |