FDA.reportPublic FDA data

MAUDE MDR 289720

MDR report key
289720
Report number
1218813-2000-00003
Event key
0
Event type
3
Date of event
1998-12-02
Date received
2000-08-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
87 RUMFORD AVE WALTHAM MA 02454 US
Phone
781-781-7818
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MIRAGELSCLERAL BUCKLING COMPONENTMIRA INCHQJUNKUNKUNKYRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-08-1101. R

Event Narratives#

D

Patient 1

IMPAIRMENT OF VISION IN RIGHT EYE DUE TO DEFICIENCIES AND PROBLEMS WITH SCLERAL"EXOPLANT"(MIRAGEL).