MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2012-05-24 for PERFLUORON 8065900106 manufactured by Alcon - Fort Worth / Alcon Laboratories, Inc..
[2790153]
A journal abstract reported a case of perfluoron (pfcl) residue under the fovea that was able to be removed from the eye filled with silicone oil (so). The abstract reported a (b)(6) who reported decreasing visual acuity for several months prior to his visit. Upon examination, a full thickness retinal detachment and a strong fold was found (pvr grade c). Three vitrectomies were performed using pfcl and so. The day after the final vitrectomy, a circular ridge on the macula was found via optical coherence tomography (oct). A central scotoma was found on visual field testing. The surgeon judged the symptoms to be caused by pfcl residue under the macula. A surgical procedure was performed forty two days following the last surgical procedure. The surgeon injected balanced salt solution (bss) into the subretinal space from the upper side of under the fovea, and the pfcl residue was discharged from the retina. After surgery, the circular ridge disappeared but the va was 0. 1 (20/200). There was no retinal re-detachment and the so quantity was noted to be decreasing. The authors concluded that pfcl residue could be removed though the eye was filled with so.
Patient Sequence No: 1, Text Type: D, B5
[9889632]
Eval summary: no lot code or sample was provided by the customer. No further eval is possible at this time. Based on the complaint report, the most probable cause is the user not following the labeling instructions. Emoto, j. A case report pfcl residue under the fovea was able to be removed from the eye filled with silicone oil. Presented at the 35th japanese society of ophthalmic surgeons. (b)(4). Conclusion: we could remove the pfcl residue though the eye was filled with so. We suggest the early pfcl removal treatment though the eye is needed continuous so tamponade.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00071 |
| MDR Report Key | 2593318 |
| Report Source | 01,03 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-04-24 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-04-24 |
| Date Added to Maude | 2012-06-01 |
| 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 | PAUL NITSCHMANN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-16 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152440 |
| 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 | 2012-05-24 |
| Model Number | 8065900106 |
| Catalog Number | 8065900106 |
| 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 | 2012-05-24 |