FDA.reportPublic FDA data

MAUDE MDR 21768699

MDR report key
21768699
Report number
3010126268-2025-00009
Event key
0
Event type
3
Date of event
2025-03-18
Date received
2025-04-03
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
100
Health professional
1
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
MR. MANJAYA MANJAYA
Address
5300 CENTRAL PARKWAY DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
438805CT LUCIACT LUCIA 621PCARL ZEISS MEDITEC PRODUCTION LLCHQL621P003500-0056-4843S230401YN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12025-04-030R

Event Narratives#

N

Patient 0

THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMITIES OR DEVIATIONS NOTED DURING THE MANUFACTURING OF THE LENS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE NATURE OF THIS COMPLAINT. ADDITIONALLY, OUR LENSES ARE 100% INSPECTED BEFORE THEY LEAVE OUR MANUFACTURING SITE. THEREFORE, WE ARE CONFIDENT THAT THE LENS WAS PROCESSED PER STANDARD OPERATING PROCEDURES AND INSPECTIONS AND HAVE MET ALL CRITERIA FOR RELEASE.

D

Patient 0

IT WAS REPORTED THAT DURING A PROCEDURE, THE HAPTIC OF THE IMPLANTED CT LUCIA 621P LENS SHEARED OFF AND AS A RESULT THE DOCTOR HAD TO EXPLANT THE DAMAGED LENS AND IMPLANT A BACKUP LENS.