MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-17 for LUXOR OPHTHALMIC MICROSCOPES LX3 8065753062 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[108507544]
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
[108507545]
A customer reported that during a cataract procedure, the microscope would not focus up or down. The case was aborted. The eye was filled with viscoelastic and the wound was closed. The patient was transported from operating room one to operating room three. The case was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
[117340713]
The system was examined and the reported event was confirmed (via event log review). The focus clutch assembly was adjusted, which resolved the issue. 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 system was manufactured on february 14, 2018. Based on qa assessment, the product met specifications at the time of release. The root cause can be attributed to a non-conforming focus clutch assembly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2018-01023 |
| MDR Report Key | 7521913 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-17 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2018-05-17 |
| 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. BRYAN BLAKE |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUXOR OPHTHALMIC MICROSCOPES |
| Generic Name | MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2018-05-17 |
| Model Number | LX3 |
| Catalog Number | 8065753062 |
| Lot Number | NA |
| ID Number | 380657530625 |
| 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. Required No Informationntervention | 2018-05-17 |