FDA.reportPublic FDA data

MAUDE MDR 9818693

MDR report key
9818693
Report number
1119421-2020-00425
Event key
0
Event type
3
Date received
2020-03-11
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. 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 TORIC SINGLEPIECE IOLLENS, INTRAOCULAR, TORIC OPTICSALCON RESEARCH, LLC - HUNTINGTONMJPSN6AT4SN6AT4.22512378891R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1101. R

Event Narratives#

N

Patient 1

EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

D

Patient 1

A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A RESIDUAL REFRACTIVE ERROR. THE PATIENT REPORTED BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE TEN DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.