FDA.reportPublic FDA data

MAUDE MDR 6647126

MDR report key
6647126
Report number
3008564898-2017-00001
Event key
0
Event type
3
Date of event
2017-05-12
Date received
2017-06-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. WILLIAM GUSTAFSON
Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPMI LUMERA 300MICROSCOPE, OPHTHALMICCARL ZEISS SUZHOU CO.,LTDHRM3006137NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-1601. O

Event Narratives#

N

Patient 1

THE MANUFACTURER INSPECTED THE OPMI LUMERA 300 AND CONFIRMED THAT THE DEVICE IS WORKING WITHIN MANUFACTURER'S SPECIFICATION. THE RED REFLEX FEATURE OF THE MICROSCOPE WAS AVAILABLE DURING INSPECTION BOTH THROUGH THE OPTICS AND THE MONITOR. THE MANUFACTURER WAS NOT ABLE TO OBTAIN INFORMATION ABOUT THE SETTINGS USED BY THE HCP. UNFAVORABLE USER'S SETTINGS OF THE FIELD ILLUMINATION AND THE ANATOMY OF THE EYE CAN HAVE AN IMPACT TO THE QUALITY OF THE RED REFLEX AND THE SURGEON'S VIEW. THE USER MANUAL (G-30-1947-EN, VERSION 1.7, PAGE 90) CONTAINS INSTRUCTIONS ABOUT HOW TO SET UP THE MICROSCOPE AND HOW TO REACT IN CASE OF AN ISSUE. "ALWAYS CHECK THE FUNCTION OF THE SYSTEM BEFORE SURGERY (WITHOUT PATIENT)". "CHECK THE RETINA PROTECTION FILTER AND THE RED REFLEX FOR PROPER FUNCTION". "IF THE FAILURE OF A FUNCTION IMPAIRS YOUR WORK, DO NOT USE THE SYSTEM FOR SAFETY REASONS!".

D

Patient 1

THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING A DENSE CATARACT PROCEDURE, THE RED REFLEX FEATURE OF THE OPMI LUMERA 300 WAS NOT AVAILABLE. THEREFORE, IT WAS DIFFICULT TO SEE THE POSTERIOR PART OF THE CAPSULAR BAG IN THE PATIENT'S EYE AND THE HCP ENDED UP RUPTURING THE CAPSULAR BAG. THE PATIENT RECEIVED AN ADDITIONAL VITRECTOMY TREATMENT IN A SECOND SURGERY. THE HCP REPORTED THAT ONE WEEK POST SURGERY, THE PATIENT IS RECOVERING WELL. ALL PERTINENT INFORMATION AVAILABLE TO CARL ZEISS MEDITEC HAS BEEN SUBMITTED IN THIS REPORT.