MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for WAVELIGHT OB820 8065990814 manufactured by Wavelight Gmbh.
[59846149]
At the visit on site the field service engineer performed checkup of optics and mechanical parts of device as part of the routine preventive maintenance. The technician did not find any defect or non-conformance. The technician cleaned the optics. The technician performed verification of device according to company standards and found device meets all safety and functional parameters. The device history records (dhr) for the device was reviewed. No abnormalities that could have contributed to this event were found. The associated device was released based on acceptance criteria. There is no indication a device malfunction or inappropriate labelling caused or contributed to the reported event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59846150]
A nurse reported that the target refraction for the left eye was calculated at -2. 00 diopters but the final refraction for the patient is plano. Additional information received states that the patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2016-01997 |
| MDR Report Key | 6087746 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2016-10-14 |
| Device Manufacturer Date | 2010-02-02 |
| Date Added to Maude | 2016-11-08 |
| 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 | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | WAVELIGHT GMBH |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WAVELIGHT OB820 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2016-11-08 |
| Model Number | NA |
| Catalog Number | 8065990814 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH |
| Manufacturer Address | AM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-08 |