PERFLUORON

MAUDE Adverse Event Report

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..

Event Text Entries

[52949070] 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


[52949071] 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 fourth 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


MAUDE Entry Details

Report Number1610287-2016-00093
MDR Report Key5903084
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-08-25
Date of Report2016-08-24
Date Mfgr Received2016-07-28
Date Added to Maude2016-08-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. RITA LOPEZ
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514846
Manufacturer G1ALCON LABORATORIES, INC.
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal Code76134
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePERFLUORON
Generic NameFLUID, INTRAOCULAR
Product CodeLWL
Date Received2016-08-25
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON LABORATORIES, INC.
Manufacturer Address6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-08-25

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