FDA.reportPublic FDA data

MAUDE MDR 1877606

MDR report key
1877606
Report number
1057129-2010-00016
Event key
0
Event type
3
Date of event
2008-06-11
Date received
2010-10-15
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
KENT IVERSEN
Address
15 DART RD. NEWNAN GA 30265 US
Phone
678-678-6784
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDPOR OCULAR SCREW AND ACCESSORIESMEDPOR OCULAR SCREW AND ACCESSORIESPOREX SURGICALMQUNA89103UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-10-1501. O

Event Narratives#

D

Patient 1

THE OCULARIST STATED THAT HE SAW THE PT FOR FITTING OF PROSTHESIS TO THE RIGHT EYE USING THE MEDPOR ATTRACTOR COUPLING SYSTEM ON (B)(6) 2007. THE OCULARIST TOOK IMPRESSION USING THE AQUASIL ULTRA L.V. THE DOCTOR STATED THAT THE POSITION OF THE ATTRACTOR WAS VISIBLE, ALTHOUGH NOT CLEARLY. THE OCULARIST STATED THAT HE PLACED THREE MAGNETS IN THE PROSTHESIS WITH GOOD RESULTS ON (B)(6) 2007. THE OCULARIST STATED THAT THE PT PRESENTED WITH UPPER-LID PTOSIS ON (B)(6) 2007. THE OCULARIST STATED THAT THE UPPER-LID PTOSIS WAS CORRECTED BY BULKING UP CORNEAL AREA. THE OCULARIST STATED THAT THE PTOSIS WAS DUE TO DECREASE IN SWELLING. THE OCULARIST STATED THAT THE SOCKET WAS SLIGHTLY INJECTED AFTER REMOVAL OF SOME OF THE STITCHES AND THE PLASTIC OVER THE MAGNETS AND THE CONJUNCTIVA AT THE MAGNET SITE WERE NOT DAMAGED. THE OCULARIST REPORTED THAT ON (B)(6) 2008, THE PT PRESENTED WITH EXPOSURE OF 15MM. THE OCULARIST STATED THAT SOME DEEPER STITCHES WERE REMOVED TWO WEEKS PRIOR TO THE EXPOSURE AND THE DOCTOR PRESCRIBED MAXITROL AND ACULAR. THE OCULARIST REPORTED THAT HE REMOVED THE MAGNET FROM THE PROSTHESIS BUT IT RESULTED IN INFERIOR LATERAL DECENTRATION. THE OCULARIST REPORTED THAT HE RESTARTED NEW PROSTHESIS. IMPRESSION TAKEN WITH THE AQUASIL ULTRA XLV.

N

Patient 1

THE DEVICE INFO WAS NOT PROVIDED BY THE OCULARIST; THEREFORE AN INVESTIGATION COULD NOT BE CONDUCTED ON THE DEVICE.