MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-25 for PERFLUORON manufactured by Alcon Laboratories, Inc..
[52947802]
No data regarding product identity were indicated for the event; therefore, the device history record (dhr) could not be reviewed. No sample was returned, therefore, the condition of the product could not be verified. Because a sample was not returned and no lot number or serial number were indicated for this complaint, the root cause cannot be determined. The directions for use (dfu) for this product states: pfo must be completely removed at the conclusion of the procedure by aspiration through either a 23 gauge or flute needle during the air-fluid exchange, or by direct exchange with an appropriate long-term vitreous substitute. Failure to remove may result in visual abnormalities and secondary surgical intervention. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52947803]
In a literature article information was presented with regard to retrospective study of a cluster of six cases of retained intraocular perfluoron (pfo) that occurred after pars plana vitrectomy (ppv) for retinal detachment repair. Pfo was noted in the anterior chamber (ac) and/or vitreous and removed with ac paracentesis, ac wash-out, and/or ppv. These cases were noted shortly after the facility transitioned from non-valved trocar cannulas to valved trocar cannulas between (b)(6) 2012 through (b)(6) 2013. This is the first of six reports. Reference: oellers p, schneider e, fekrat s, mahmoud t, mruthyunjaya p, hahn p. Retained intraocular perfluoro-n-octane after valved cannula pars plana vitrectomy for retinal detachment. Ophthalmic surg lasers imaging retina. 2015; 46: 451-456.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2016-00090 |
| MDR Report Key | 5903088 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-24 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-08-25 |
| 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 | 3 |
| Manufacturer Contact | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 |
| 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 | 2016-08-25 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2016-08-25 |