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..
[52949906]
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 was 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
[52949907]
In a literature article information was presented with regard to a 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 may 16, 2012 through january 7, 2013. This is the sixth 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 | 1610287-2016-00095 |
| MDR Report Key | 5903082 |
| 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 |