FDA.reportPublic FDA data

MAUDE MDR 9665039

MDR report key
9665039
Report number
2523835-2020-00025
Event key
0
Event type
3
Date of event
2020-01-15
Date received
2020-02-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JASON MICHAELIDES
Address
6201 SOUTH FREEWAY MAIL STOP AB2-6 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
1CYPASS SYSTEMINTRAOCULAR PRESSURE LOWERING IMPLANTTRANSCEND MEDICAL INC.OGONACYP-241ASKUR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0401. O; 2. R

Event Narratives#

N

Patient 1

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

D

Patient 1

A CUSTOMER REPORTED FOLLOWING THE IMPLANT OF A MICRO-STENT FILTRATION DEVICE, HER SIGHT STARTED TO DETERORIATE. EVERYTHING WAS GETTING CLOUDY. SHE WAS PLACED BACK ON EYE DROPS AND WAS TOLD THE DEVICE 'DID NOT WORK FOR HER'. SHE RETURNED TO THE DOCTOR AND WAS TOLD THE DEVICE WAS ON RECALL. SHE REPORTS SHE IS NOW LEGALLY BLIND AND USES A CANE. SHE HAS EXPERIENCED PAIN AND HER 'IOL WENT UP'. ADDITIONAL INFORMATION WAS REQUESTED.