MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) MILOOP ®

Model Number	MILOOP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cataract (1766); Vitreous Loss (2142); Capsular Bag Tear (2639); Foreign Body In Patient (2687)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: MILOOP ®
• Common Device Name: MILOOP
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9255574100
• MDR Report Key: 24434349
• Report Number: 9615010-2026-00002
• Device Sequence Number: 10297644
• Product Code: HNQ
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MILOOP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICOR LENS FRAGMENTATION SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male