MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-03-30 for OPMI VISU 210 ON S88 FLOORSTAND 302606-9901-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[103968546]
There is no evidence to show that the use of the microscope caused or contributed to the injuries reported. In the medsun mandatory and voluntary report form (b)(4) submitted to the fda, the site's risk program manager listed opmi vario as the device involved in the event. On march 5, 2018, the site's biomedical engineer confirmed that the device listed on the voluntary report is incorrect. The device that was involved in the incident was an opmi visu 210, serial number (b)(4). It was also learned that the device had been serviced by a third-party, not affiliated with zeiss.
Patient Sequence No: 1, Text Type: N, H10
[103968547]
A health care professional (hcp) reported that the primary lamp of the opmi visu 210 on a s88 floor stand went out during a cataract extraction procedure. The hcp switched to the backup lamp; however, the light intensity of the backup lamp was not sufficient. It was reported that the patient sustained an iris prolapse, capsular tear, zonular dehiscence and corneal edema.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00006 |
| MDR Report Key | 7385684 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-03-30 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2006-10-27 |
| Date Added to Maude | 2018-03-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI VISU 210 ON S88 FLOORSTAND |
| Generic Name | MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2018-03-30 |
| Model Number | VISU 210 |
| Catalog Number | 302606-9901-000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |