MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for SLIT LAMP 8065740982 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[71493604]
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
[71493605]
A healthcare professional reported that the laser power was poor. The procedure was completed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[76891940]
The system was examined and the reported event was not replicated. The company representative cleaned the optics block of the slit lamp and aligned the aiming be am to address the issue. The slip lamp was manufactured on march 31, 2010. Based on qa assessment, the system met specifications at the time of release. The system was tested and found to meet product specifications. The root cause of the reported event can be attributed to dust and debris accumulating on the slit lamp optics over time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2017-01357 |
| MDR Report Key | 6446971 |
| Date Received | 2017-03-30 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 | 3 |
| Brand Name | SLIT LAMP |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-03-30 |
| Model Number | NA |
| Catalog Number | 8065740982 |
| Lot Number | ASKU |
| ID Number | 1.04_BLD_0043 |
| 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 | 2017-03-30 |