MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2011-02-11 for PERFLUORON 8065900113 manufactured by Alcon - Fort Worth / Alcon Laboratories, Inc..
[1712192]
Literature article reports: a (b)(6) year-old, male, underwent surgery to repair a giant retinal tear. A vitrectomy was performed and perfluoro-n-octane (pfo) was used. Three months following initial surgery, the surgeon noted pfo residues under the retina. There was no scotoma corresponding to the position of the pfo residue and there were no subjective symptoms. The prognosis is being observed. This is the third of four medical device reports being reported for this literature report.
Patient Sequence No: 1, Text Type: D, B5
[8958067]
The product insert / directions for use (dfu) states perfluoron must be completely removed from the eye and replaced with an appropriate vitreous substitute. Also the literature provides precautions to avoid inadvertent placement of perfluoron behind the retina during injection, the final fill level in the eye should always remain posterior to any large retinal breaks, additionally, the literature states if perfluoron is introduced into a large retinal break, it may slip into the subretinal space. Special care should be taken to examine for and remove any subretinal perfluoron through an existing posterior tear or through a posterior retinotomy prior to completion of surgery. No lot code was provided and no sample was returned so no further investigation could be performed at this time. Literature citation: hajime bando, toshihide ikeda, takamasa minami, eriko nakatani, ryo iishi, tomohito tanaka, kosaku sawada, yoshihito oura, tatsuhiko sato and kazuyuki emi: analysis of cases with perfluorocarbon liquid remaining in eyes. Abstracts of the 34th annual meeting of the (b)(6) society of ophthalmology. (b)(4). This report was mailed to fda on: 02/11/2011. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2011-00014 |
| MDR Report Key | 1993666 |
| Report Source | 01,03 |
| Date Received | 2011-02-11 |
| Date of Report | 2011-01-12 |
| Date of Event | 2011-06-25 |
| Date Mfgr Received | 2011-01-12 |
| Date Added to Maude | 2011-02-18 |
| 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 | PERFLUORON |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2011-02-11 |
| Model Number | 8065900113 |
| Catalog Number | 8065900113 |
| 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. Other | 2011-02-11 |