FDA.reportPublic FDA data

MAUDE MDR 9908148

MDR report key
9908148
Report number
1119421-2020-00573
Event key
0
Event type
3
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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 TRIFOCAL IOLLENS, MULTIFOCALALCON RESEARCH, LLC - HUNTINGTONMFKTFNT00TFNT00U24512743601R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

D

Patient 1

A SURGICAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND DIPLOPIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS SEVEN WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. FAILED REFRACTIVE SYMPTOM TREATMENT FOR BLURRY VISION AND DIPLOPIA WAS THE CLINICAL REASON GIVEN FOR THE EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.