MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-12-18 for ELITE E85 * manufactured by Lumenis, Inc..
[18112312]
Physican was performing panretinal photocoagulation for thrombosis of the main central retinal vein using the elite at parameters of 200mw, 200 micron spot and 0. 1 second exposure. A sudden hemorrhage occurred and completely obscured treatment visibility. Treatment was terminated. No further medical intervention was performed. Patient vision prior to treatment was 20/200 and following the subsequent hemorrhage, the patient had no vision in the treated eye. Physician expects vision to return to 20/200 once blood in the field is absorbed. Follow-up is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2003-00002 |
| MDR Report Key | 502822 |
| Report Source | 05 |
| Date Received | 2003-12-18 |
| Date of Report | 2003-12-12 |
| Date of Event | 2003-11-11 |
| Date Mfgr Received | 2003-11-20 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2003-12-29 |
| 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 | 0 |
| Manufacturer Contact | KAREN BAKER |
| Manufacturer Street | 2400 CONDENSA STREET |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4087643603 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE E85 |
| Generic Name | OPHTHALMIC LASERS |
| Product Code | HQB |
| Date Received | 2003-12-18 |
| Returned To Mfg | 2003-12-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 491596 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-18 |