FDA.reportPublic FDA data

MAUDE MDR 9894750

MDR report key
9894750
Report number
1119421-2020-00527
Event key
0
Event type
3
Date of event
2020-03-03
Date received
2020-03-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JONATHAN SCHLECH
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
1ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOLLENS, MULTIFOCALALCON RESEARCH, LLC - HUNTINGTONMFKTFNT40TFNT40.17012669599* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2801. R

Event Narratives#

N

Patient 1

A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

D

Patient 1

A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT EXPERIENCED LIGHT GLARE AND WAS UNABLE TO SEE FAR DISTANCE CLEARLY COMPARED TO THE FELLOW EYE. AN IOL EXCHANGE PROCEDURE WAS PERFORMED TWO WEEKS FOLLOWING THE INITIAL PROCEDURE FOR ANOTHER LENS MODEL WITH ONE DIOPTER MORE POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.