MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2013-07-02 for PERFLUORON 8065900112 manufactured by Alcon - Fort Worth/alcon Laboratories, Inc.
[3631199]
In a journal article describing a series of 157 pts with inferior retinal detachments managed with primary 25-gauge pars plana vitrectomy (ppv), 2 to 3 weeks (medium-term) of postoperative perfluoro-octane (pfo) tamponade, and upright positioning followed by secondary ppv and pfo removal; the investigator reported that some pts experienced a granulomatous inflammatory reaction and some pts experienced persistent intraocular pressure (iop) elevation. Pts who experienced inflammation received topical and/or periocular corticosteroid therapy. Some pts who experienced persistent iop elevation progressed to filtering surgery. Per the product labeling, perfluoro-n-octane must be completely removed at the end of the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[10886659]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable info becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2013-00022 |
| MDR Report Key | 3207243 |
| Report Source | 03,05 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-06-06 |
| Date Mfgr Received | 2013-06-06 |
| Date Added to Maude | 2013-07-08 |
| 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 | ARTHUR CIOCIOLA |
| Manufacturer Street | 6201 S FREEWAY, TC-40 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152442 |
| 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 | 2013-07-02 |
| Model Number | 8065900112 |
| Catalog Number | 8065900112 |
| 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 | 2013-07-02 |