MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2014-05-05 for PERFLUORON 8065900112 manufactured by Alcon - Fort Worth/alcon Laboratories, Inc..
[4448249]
In a journal article describing a study of 181 patients with inferior retinal detachment treated with intermediate duration postoperative vitreous cavity per fluoro-n-octane in approximately 30 percent of the patients which was apparent at seven to ten days after the initial product instillation for rhegmatogenous retinal detachment repair was performed. No further information is expected for this literature report.
Patient Sequence No: 1, Text Type: D, B5
[11742288]
No product lot code or sample is available in conjunction with this literature report. With no lot code information or complaint sample, no further evaluation can be performed. Per the product labeling, perfluoro-n-octane must be completely removed at the end of the surgical procedure. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2014-00054 |
| MDR Report Key | 3830559 |
| Report Source | 03,05 |
| Date Received | 2014-05-05 |
| Date of Report | 2014-04-11 |
| Date Mfgr Received | 2014-04-11 |
| Date Added to Maude | 2014-05-27 |
| 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 | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| 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 | PERFLUORON |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2014-05-05 |
| Model Number | 8065900112 |
| Catalog Number | 8065900112 |
| Lot Number | UNK |
| 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, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-05 |