MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-13 for 25+ ENDOILLUNIMATOR * 8065751486 manufactured by Alcon Research, Ltd..
[6056145]
The patient's intraoperative course was complicated by a extraocular foreign body, which was perceived to be attached to the light pipe. The intraocular foreign body was reduced and removed using the vitrectomy device. At the conclusion of surgery, there was no evidence of intraocular foreign body in the eye. Once vitrectomy had commenced, a small clear semi-cylindrical foreign body was identified in the eye. It was uncertain as to the exact source of this object. It was thought to be perceived the light pipe, based on its pseudo-cylindrical shape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4924450 |
| MDR Report Key | 4924450 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-07-09 |
| Report Date | 2015-07-13 |
| Date Reported to FDA | 2015-07-13 |
| Date Reported to Mfgr | 2015-07-20 |
| Date Added to Maude | 2015-07-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25+ ENDOILLUNIMATOR |
| Generic Name | ENDOSCOPE AND ACCESSORIES. |
| Product Code | MPA |
| Date Received | 2015-07-13 |
| Model Number | * |
| Catalog Number | 8065751486 |
| Lot Number | 1674091H |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH, TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-13 |