MAUDE MDR 24434349

MDR report key
24434349
Report number
9615010-2026-00002
Event key
0
Event type
3
Date of event
2026-01-12
Date received
2026-02-24
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
229922MILOOP ?MILOOPCARL ZEISS MEDITEC AG (OBERKOCHEN)HNQMILOOPNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-02-240R

Event Narratives#

D

Patient 0

A PATIENT WITH A HYPER-MATURE CATARACT AND A HISTORY OF KERATOCONUS AND COLLAGEN CROSSLINKING UNDERWENT CATARACT SURGERY IN THE RIGHT EYE. THE MILOOP LENS FRAGMENTATION DEVICE WAS USED TO SECTION THE CATARACT AND TWO CUTS WERE MADE. THE MILOOP WAS PROPERLY ORIENTED AND WELL CENTERED; HOWEVER, THE DEVICE DID NOT FULLY CIRCUMNAVIGATE THE LENS. WHEN ATTEMPTING TO ROTATE THE MILOOP AND SWEEP, PRESSURE WAS INADVERTENTLY APPLIED TO THE EDGE OF THE LENS, CAUSING PRESSURE AND LENS TILT ON THE OPPOSITE SIDE. THE SURGEON PROCEEDED TO BEGIN LENS REMOVAL USING THE MICOR LENS FRAGMENTATION SYSTEM AND THE LENS SEPARATED INTO TWO HALVES. WHILE WORKING ON ONE HALF, THE OTHER LENS SEGMENT WAS FLOATING ON THE OPPOSITE SIDE AND DROPPED IMMEDIATELY INTO THE POSTERIOR CHAMBER. THE SURGEON CONTINUED REMOVING THE REMAINING LENS SEGMENT USING MICOR WHICH WAS COMPLETED SUCCESSFULLY. THE SURGEON THEN CONVERTED TO PHACOEMULSIFICATION TO PERFORM AN ANTERIOR VITRECTOMY AND IMPLANTED A 3-PIECE INTRAOCULAR LENS IN THE SULCUS. THE NUCLEUS REMNANT WAS LEFT IN THE VITREOUS CAVITY AND THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. THE SURGEON STATED THAT AS PRESSURE WAS APPLIED DURING THE MILOOP PORTION OF THE SURGERY, THE ZONULES STRETCHED, POTENTIALLY COMPROMISING THE INTEGRITY OF THE CAPSULAR BAG WHICH ALLOWED VITREOUS PROLAPSE AND SUBSEQUENT LENS DROP DURING MICOR. PATIENT FOLLOW-UP INFORMATION IS BEING REQUESTED FROM THE PHYSICIAN'S OFFICE.