MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-07-30 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth/ Alcon Laboratories, Ltd..
[21018026]
Adverse event(s): "optic neuritis" (optical nerve damage). Product problem(s): "no information" (no information). A surgeon reported that optic neuritis was observed in a pt following intraocular surgery where silicone oil was used. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[21235189]
The product was not returned for analysis; device remains implanted. Product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2010-00092 |
| MDR Report Key | 1784706 |
| Report Source | 01,05 |
| Date Received | 2010-07-30 |
| Date of Report | 2010-06-30 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-06-30 |
| Date Added to Maude | 2010-08-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY R7-18 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON - FORT WORTH/ALCON LABORATORIES, INC |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILIKON 1000 OIL |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2010-07-30 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - FORT WORTH/ ALCON LABORATORIES, LTD. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-07-30 |