MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-02-16 for PERFLUORON 80659001AB manufactured by Alcon Laboratories, Inc..
[38227652]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21cfr 803. 56 when additional reportable information becomes available. Additional information has been requested but not received to date. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[38227653]
A healthcare professional reported that ophthalmic perfluorocarbon liquid was used in a posterior vitrectomy surgery after which the patient experienced macular fibrosis, atrophy of the optic nerve and difficult light perception in the left eye (os). The surgery was without complications but patient had an unexpected evolution. There were no chances of visual improvement in the eye. Additional information has been requested but not received to date.
Patient Sequence No: 1, Text Type: D, B5
[40538906]
Patient Sequence No: 1, Text Type: N, H10
[40538907]
Additional information was provided by the ophthalmology head service. The patient was not hospitalized. No medical intervention was required to treat the event. Accordig to the surgeon's opinion, it is unknown if the device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2016-00007 |
| MDR Report Key | 5438030 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-02-16 |
| Date of Report | 2016-03-17 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2016-02-23 |
| Date Added to Maude | 2016-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | ALCON LABORATORIES, INC. |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFLUORON |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2016-02-16 |
| Model Number | NA |
| Catalog Number | 80659001AB |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-02-16 |