FDA.reportPublic FDA data

MAUDE MDR 9645558

MDR report key
9645558
Report number
3002806902-2020-00001
Event key
0
Event type
3
Date of event
2019-12-02
Date received
2020-01-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MS RASHMI PILLAY
Address
3-4 SECOND AVENUE MAWSON LAKES, SOUTH AUSTRALIA 5095 AS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TANGOOPHTHALMIC LASERELLEX MEDICAL PTY LTDHQFLT5106-TY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-3001. O

Event Narratives#

N

Patient 1

THE SYSTEM WAS QUARANTINED BY THE USER FACILITY ONLY ON 30TH DECEMBER AND THE EVENT REPORTED TO ELLEX ON 3RD JANUARY. AS CONFIRMED BY THE SERVICE ENGINEER FOR ELLEX (B)(4), THERE WERE NO REPORTED COMPLAINTS /ADVERSE EVENTS DURING THIS PERIOD BEFORE THE SYSTEM WAS QUARANTINED AND THE EVENT OCCURRENCE AND ALSO BEFORE THE EVENT OCCURRED. THE DEVICE VERIFICATION (PAF) WAS DONE ON 16TH JAN 2020 AND THE SYSTEM WORKED TO SPECIFICATION. IT'S NOT CLEAR WHETHER THE INJURY WAS SERIOUS, AS THERE WAS NO FEEDBACK ON WHERE (PART OF THE EYE) THE INJURY OCCURRED AND ALSO NO DETAILS ON WHETHER A MEDICAL INTERVENTION WAS REQUIRED, THE PATIENT STATUS NOR THE DEVICE SETTINGS USED. AS NO INFORMATION WAS FORTHCOMING AND THE DEVICE WORKED WELL WITHIN SPECIFICATION AND THE INITIAL COMPLAINT REFERENCE MENTIONED [?] THE USER NOT USING THE SYSTEM CORRECTLY. THE ONLY PROBABLE CAUSE AS ADVISED BY THE CLINICIAN, COULD BE THE USER CHOOSING THE WRONG MODE (SLT INSTEAD OF YAG) WHICH COULD HAVE LED TO THIS EVENT. AN EVALUATION OF THE LABELING / DEVICE "USUABILITY" WAS DONE AND IT WAS DEEMED ADEQUATE.

D

Patient 1

PATIENT UNDERWENT CAPSULOTOMY AT 0.9MJ AND EXPERIENCED OCULAR HEMORRHAGE.