MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for LUXOR OPHTHALMIC MICROSCOPES LX3 8065752560 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[118874967]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118874968]
A healthcare professional reported that the microscope head feels loose and unsteady after moving the scope. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[132417292]
The system was examined and the reported event was confirmed. The company representative tightened the four inner screws in the bottom plate of the coupler above the libero to resolve the issue. The optics were also cleaned as a preventive measure. The system was tested and found to meet product specifications. The system was manufactured on june 5, 2015. Based on qa assessment, the product met specifications at the time of release. The root cause can be attributed loose screws in the libero coupler. How or when the screws became loose is unable to be determined the manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2018-01838 |
| MDR Report Key | 7833521 |
| Date Received | 2018-08-30 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2015-06-05 |
| Date Added to Maude | 2018-08-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 | LUXOR OPHTHALMIC MICROSCOPES |
| Generic Name | MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2018-08-30 |
| Model Number | LX3 |
| Catalog Number | 8065752560 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-08-30 |