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..
[21754191]
A journal abstract reported a pt who presented for treatment of myopia. Upon examination, the surgeon found a retinal detachment on the underside and the upper side atrophic hole of the lattice degeneration. A laser treatment was performed, but two weeks later, giant retinal tears and bullous retinal tears and bullous retinal detachment were noted. A vitrectomy and perfluoron (pfcl) and silicone oil (so) tamponade performed. One month following this procedure, the so was noted to have moved to the anterior chamber. The pt was noted to have ocular hypertension. The so was removed from the eye. Following removal of the so, pcfl residue was found under the ear side of the macula. The surgeon removed the internal limiting membrane (ilm) using brilliant green and aspirated the pcfl using a blunt needle. An air liquid tamponade was performed. One month following the pcfl removal, the pt's visual acuity had recovered. No hole or retinal damage was noted in the aspiration area. An ocular coherence tomography (oct) was normal. The authors concluded that pfcl residue was able to be safely removed with the ilm detachment. There are two medical device reports associated with this event. This report is for the perfluoron.
Patient Sequence No: 1, Text Type: D, B5
[21859016]
Eval summary: the complaint device was not rec'd for eval. Product history records could not be reviewed because the rptr did not provide a lot number or any identification traceable to the mfg documentation. Based on the complaint report the most probable cause is the user following the label instructions. Iwasaki, t. Removal pfcl residues under the retina with ilm detachment treatment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00072 |
| MDR Report Key | 2593317 |
| 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 |