MAUDE Adverse Event Report: CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. MICOR LENS FRAGMENTATION SYSTEM; PHACOFRAGMENTATION SYSTEM

Model Number	FG-50621
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Foreign Body In Patient (2687)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent cataract surgery in the left eye where the micor lens fragmentation system was used to remove the cataractous lens fragments.A posterior capsular tear occurred during surgery and a portion of the lens nucleus fell posteriorly into the vitreous cavity.The nucleus remnant was left behind for the retina specialist to address and a 3-piece intraocular lens was implanted in the sulcus.The surgeon was unsure when the capsule rupture occurred.Patient follow-up information was requested from the physician's office on three separate occasions, but no additional information is available at this time.
Additional Manufacturer Narrative
The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection and functional testing, which consisted of flow, vacuum, surge, and cutter testing.There was no damage or device malfunction identified and the device met specifications and performed as intended.The micor extractor device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).

• Brand Name: MICOR LENS FRAGMENTATION SYSTEM
• Common Device Name: PHACOFRAGMENTATION SYSTEM
• Manufacturer (Section D): CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC.; 8740 technology way; reno NV 89521
• Manufacturer (Section G): CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.; 8740 technology way; reno NV 89521
• Manufacturer Contact: andrew rybold ; 8740 technology way; reno, NV 89521 ; 7754731014
• MDR Report Key: 23343408
• Report Number: 3012123033-2025-00004
• Device Sequence Number: 7807050
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K242801
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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 Expiration Date: 09/07/2025
• Device Model Number: FG-50621
• Device Lot Number: FG24070210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown