FDA.reportPublic FDA data

MAUDE MDR 1673408

MDR report key
1673408
Report number
2242450-2010-00002
Event key
0
Event type
3
Date of event
2010-02-25
Date received
2010-04-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
4 STEWART COURT DENVILLE NJ 07834 US
Phone
973-973-9739
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHANG PHACO CHOPPERPHACO CHOPPERKATENA PRODUCTS, INC.HNZK3-2369K3-2369NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-2401. R

Event Narratives#

D

Patient 1

USER FACILITY VOLUNTARY REPORT DATED (B) (4) 2010; STATED: "DURING CATARACT PROCEDURE ON RIGHT EYE, THE PHYSICIAN NOTICED THE MICROTIP OF THE PHACO CHOPPER MISSING. THE RIGHT EYE WAS IRRIGATED CONTINUOUSLY AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN WAS UNABLE TO VISUALIZE THE TIP WITH OPHTHALMOSCOPE. AN X-RAY WAS DONE AND THE TIP WAS NOT SEEN."

N

Patient 1

RECEIVED PAGE 1 ONLY OF USER FACILITY VOLUNTARY REPORT (FORM 3500) DATED (B) (4) 2010 VIA POSTAL SERVICE ON 03/25/2010. OF USER FACILITY VOLUNTARY REPORT (3500) INDICATED DEVICE AVAILABLE FOR EVALUATION. MANUFACTURER CONTACTED THE USER FACILITY ON SEVERAL OCCASIONS, LEFT MESSAGES FOR THE RISK MANAGER, AND USER FACILITY NEVER RETURNED CALLS OR FORWARDED THE SUBJECT DEVICE FOR MANUFACTURER'S EVALUATION. WITHOUT HAVING THE ACTUAL SUBJECT DEVICE AVAILABLE FOR EVALUATION, OR THE ABILITY TO DISCUSS THE EVENT WITH THE USER FACILITY AND/OR USER; THE MANUFACTURERS EVALUATION WAS LIMITED TO THE REVIEW OF THE SAME DEVICE CURRENTLY HELD IN THE MANUFACTURER'S CONTROLLED FINISHED GOODS INVENTORY AND A REVIEW OF THE DEVICE HISTORY RECORDS AND FIELD USE HISTORY. MAGNIFIED VISUAL EXAMINATION OF DEVICES IN THE MANUFACTURERS CONTROLLED INVENTORY, FOUND NO ANOMALIES AND CONFIRMED ALL UNITS ARE WITHIN SPECIFIED TOLERANCES. DEVICE HISTORY RECORDS WERE ALSO CONFIRMED TO BE IN ORDER NO ANOMALIES. BASED ON THIS, NO FINAL CONCLUSIONS CAN BE DRAWN CONCERNING THE REPORTED EVENT. (B) (4). (B) (4). THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.