FDA.reportPublic FDA data

MAUDE MDR 1993671

MDR report key
1993671
Report number
1610287-2011-00013
Event key
0
Event type
3
Date of event
2009-11-20
Date received
2011-02-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHARLES DOLBEE
Address
6201 SOUTH FREEWAY R7-18 FORT WORTH TX 76134 US
Phone
817-817-8175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERFLUORONFLUID, INTRAOCULARALCON - FORTH WORTH / ALCON LABORATORIES, INC.LWL80659001138065900113UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-1101. O

Event Narratives#

N

Patient 1

THE PRODUCT INSERT / DIRECTIONS FOR USE (DFU) STATES A PERFLUORON MUST BE COMPLETELY REMOVED FROM THE EYE AND REPLACED WITH AN APPROPRIATE VITREOUS SUBSTITUTE. ALSO THE LITERATURE PROVIDES PRECAUTIONS TO AVOID INADVERTENT PLACEMENT OF PERFLUORON BEHIND THE RETINA DURING INJECTION, THE FINAL FILL LEVEL IN THE EYE SHOULD ALWAYS REMAIN POSTERIOR TO ANY LARGE RETINAL BREAKS, ADDITIONALLY, THE LITERATURE STATES IF PERFLUORON IS INTRODUCED INTO A LARGE RETINAL BREAK, IT MAY SLIP INTO THE SUBRETINAL SPACE. SPECIAL CARE SHOULD BE TAKEN TO EXAMINE FOR AND REMOVE ANY SUBRETINAL PERFLUORON THROUGH AN EXISTING POSTERIOR TEAR OR THROUGH A POSTERIOR RETINOTOMY PRIOR TO COMPLETION OF SURGERY. NO LOT CODE WAS PROVIDED AND NO SAMPLE WAS RETURNED SO NO FURTHER INVESTIGATION COULD BE PERFORMED AT THIS TIME. LITERATURE CITATION: HAJIME BANDO, TOSHIHIDE IKEDA, KOJI NAKAMIMA, TAKAMASA MINAMI, ERIKO NAKATANI, RYO IISHI, TOMOHITO TANAKA, KOSAKU SAWADA, YOSHIHITO OURA, TATSUHIKO SATO AND KAZUYUKI EMI: ANALYSIS OF CASES WITH PERFLUOROCARBON LIQUID REMAINING IN EYES. ABSTRACTS OF THE 34TH ANNUAL MEETING OF THE JAPANESE SOCIETY OF OPHTHALMOLOGY. (B)(4).

D

Patient 1

LITERATURE ARTICLE REPORTS: A (B)(6), MALE, UNDERWENT SURGERY FOR REPAIR OF A RETINAL DETACHMENT. A VITRECTOMY WAS PERFORMED AND PERFLUORO-N-OCTANE (PFO) WAS USED. TEN DAYS LATER THE PATIENT HAD AN ADDITIONAL SURGERY TO REPAIR A RETINAL RE-DETACHMENT. NO PFO WAS USED. AT THE PATIENT'S TWO MONTH EXAM, THE SURGEON NOTED PFO RESIDUES, (EIGHT SPOTS) UNDER THE RETINA, OUTSIDE OF FOVEA IN MACULA. THE TEN MONTH POST OPERATIVE EXAM, THE SURGEON NOTED VISUAL FIELD LOSS, BUT THE SURGEON THOUGHT IT MIGHT BE CAUSED BY PVR" (PROLIFERATIVE VITREORETINOPATHY). THE POSITION OF PFO RESIDUE WAS NOT CORRESPONDING TO THE VISUAL FIELD LOSS. THE PATIENT IS BEING OBSERVED. THIS IS THE SECOND OF FOUR MEDICAL DEVICE REPORTS BEING REPORTED FOR THIS LITERATURE REPORT.