FDA.reportPublic FDA data

MAUDE MDR 4280320

MDR report key
4280320
Report number
3010300699-2014-00008
Event key
0
Event type
3
Date of event
2014-10-17
Date received
2014-11-10
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
JANET MORAN
Address
6201 SOUTH FREEWAY, R3-14 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
1VERION DIGITAL MARKER M FOR LEICA MICROSCOPESCAMERA, STILL, MICROSURGICALWAVELIGHT GMBH (AGPS)FTHX-SPM8065998242NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-100

Event Narratives#

D

Patient 1

A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) ALIGNMENT TO THE VERTICAL AXIS, THE DIGITAL MARKER INDICATED A SECOND VERTICAL AXIS AT 20-30 DEGREES. THIS EVENT WAS REPORTED TO HAVE BEEN OBSERVED TWICE. NO PT HARM WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.

N

Patient 1

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).