FDA.reportPublic FDA data

MAUDE MDR 8645916

MDR report key
8645916
Report number
2523835-2019-00228
Event key
0
Event type
3
Date of event
2018-08-10
Date received
2019-05-28
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
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
1MONARCH III IOL DELIVERY SYSTEM, INJECTORLENS, GUIDE, INTRAOCULARALCON RESEARCH, LLC - ALCON PRECISION DEVICEKYBIII8065977773ASKUR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-280

Event Narratives#

N

Patient 1

NO INJECTOR WAS RETURNED FOR EVALUATION FOR THE REPORT OF THE INJECTOR DAMAGING THE LENS; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO INJECTOR LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE AN INJECTOR SAMPLE WAS NOT RETURNED AND NO LOT INFORMATION WAS PROVIDED, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

D

Patient 1

A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HANDPIECE PLUNGER MALFUNCTIONED AND DAMAGED THE LENS. THE LENS WAS NOT IMPLANTED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.