FDA.reportPublic FDA data

MAUDE MDR 8374111

MDR report key
8374111
Report number
3010300699-2019-00002
Event key
0
Event type
3
Date received
2019-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CINDY MILAM
Address
6201 SOUTH FREEWAY MAIL STOP AB2-6 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 MMARKER, OCULARWAVELIGHT GMBH (AGPS)FTHX-SPM8065998244ASKU* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-2701. 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

AN OPHTHALMOLOGIST REPORTED THAT A PATIENT DID NOT HAVE OPTIMAL RESULTS WITH TORIC INTRAOCULAR LENS. LENS WAS ROTATED BY THE HEALTHCARE PROFESSIONAL. THE HEALTHCARE PROFESSIONAL IS NOT SURE IF THE DIAGNOSTIC SYSTEM IS THE REASON FOR THE EVENT. THE DOCTOR WAS NOT ABLE TO TELL IF THE LENS WAS ACTUALLY CALCULATED BY THE DIAGNOSTIC SYSTEM OR BY ANOTHER MEASUREMENT METHOD. THE AXIS WAS IMPORTED FROM THE SYSTEM AND WERE USED TO FIT THE PATIENT. POST-OPERATIVELY, THE DOCTOR CHECKED THE PATIENT. THE DOCTOR WAS A BIT CONFUSED BECAUSE MEASUREMENTS DO NOT ALWAYS SHOW THE SAME AXIS. OTHER WAYS OF MEASURING INDICATE OTHER AXIS POSITONS. THE HEALTHCARE PROFESSIONAL'S IMPRESSION IS THAT THE PROCESS HAS BEEN COMPLICATED BY USING THE DIAGNOSTIC SYSTEM. THERE ARE TWO RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT BORN IN (B)(6) AND ANOTHER MANUFACTURER REPORT WILL BE FILED.