FDA.reportPublic FDA data

MAUDE MDR 25104924

MDR report key
25104924
Report number
3010126268-2026-00022
Event key
0
Event type
3
Date of event
2026-03-27
Date received
2026-05-06
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 HEGDE
Address
5300 CENTRAL PARKWAY DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
51635CT LUCIACT LUCIA 602CARL ZEISS MEDITEC PRODUCTION LLCHQL602003500-0050-674NN
453507CT LUCIACT LUCIA 602CARL ZEISS MEDITEC PRODUCTION LLCHQL602003500-0050-674NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-05-060R

Event Narratives#

N

Patient 0

BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR THE LUCIA 3-PIECE PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THAT THE FOLLOWING FACTOR MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE: OFF-LABEL USE OF THE YAMANE TECHNIQUE: THE CT LUCIA 602 LENS IS NOT VALIDATED FOR USE WITH THE YAMANE SCLERAL FIXATION TECHNIQUE. THIS OFF-LABEL METHOD INTRODUCES ROTATIONAL FORCES AND ANCHORING DYNAMICS THAT ARE NOT ACCOUNTED FOR IN THE DESIGN SPECIFICATIONS OF THE LENS.

D

Patient 0

CT LUCIA 602 LENS WAS PLACED IN THE EYE. TWO DAYS POST-SURGERY, THE PHYSICIAN NOTED ROTISSERIE OF THE LENS. AN EXPLANTATION OF THE LENS IS PLANNED. THE YAMANE TECHNIQUE WAS USED DURING THE PROCEDURE.