FDA.reportPublic FDA data

MAUDE MDR 2593318

MDR report key
2593318
Report number
1610287-2012-00071
Event key
0
Event type
3
Date of event
2012-01-01
Date received
2012-05-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
PAUL NITSCHMANN
Address
6201 SOUTH FREEWAY, R3-16 FORT WORTH TX 76134 US
Phone
817-817-8176
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERFLUORONFLUID, INTRAOCULARALCON - FORT WORTH / ALCON LABORATORIES, INC.LWL80659001068065900106UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-2401. R

Event Narratives#

D

Patient 1

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.

N

Patient 1

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.