FDA.reportPublic FDA data

MAUDE MDR 7620461

MDR report key
7620461
Report number
2523835-2018-00275
Event key
0
Event type
3
Date of event
2018-06-11
Date received
2018-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BRYAN BLAKE
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
1ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICCANNULA, OPHTHALMICALCON RESEARCH, LTD. - ALCON PRECISION DEVICEHMXNA8065149530ASKUR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-2001. O

Event Narratives#

N

Patient 1

NO SAMPLE OR VALID LOT NUMBER INFORMATION HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

D

Patient 1

A HEALTH PROFESSIONAL REPORTED THAT A SOFT TIP CANNULA SEEMED LONGER AND FLIMSIER AND WOULD NOT FIT THROUGH A VALVE DURING SURGERY. THE SOFT TIP WAS TRIMMED AND THE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.