FDA.reportPublic FDA data

MAUDE MDR 9848149

MDR report key
9848149
Report number
1644019-2020-00153
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-18
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
1CENTURION SURGICAL PROCEDURE PAKGENERAL SURGERY TRAY (KIT)ALCON RESEARCH, LLC - HOUSTONLRONA80657522012325505HR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-180

Event Narratives#

N

Patient 1

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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

D

Patient 1

A CUSTOMER REPORTED TO AN ACCOUNT MANAGER THE PHACOEMULSIFICATION TIP BROKE IN THE MIDDLE OF A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO INDICATED THAT DURING THE SCULPT PHASE OF A CATARACT REMOVAL WITH AN I-SENT AND INTRAOCULAR IMPLANT PROCEDURE OF THE RIGHT EYE, THE PHACOEMULSIFICATION TIP BROKE OFF THE HANDPIECE. THE SURGEON MADE ONE PASS WITH TIP WHEN HE NOTICED SOMETHING WRONG AND PULLED IT OUT OF THE EYE. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS EXPECTED.