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

Model Number	FG-50621
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent femtosecond-laser assisted cataract surgery in the right eye and the micor lens fragmentation system was used to remove the cataractous lens fragments.During lens extraction, a tear occurred in the capsular bag while manipulating one of the final lens fragments.The initial medium-sized tear became enlarged due to brief continued vacuum engagement and there was vitreous loss.The surgeon inserted viscoelastic, removed the micor extractor from the eye, and converted to phacoemulsification.An anterior vitrectomy was performed without incident.The original surgical plan was to implant a multifocal intraocular lens (iol) in the capsular bag; however, due to the intraoperative adverse event, a 3-piece monofocal iol was implanted.The lens was well-centered at the conclusion of the procedure and the patient was expected to have a favorable outcome.Additional patient follow-up was requested from the surgeon.Postoperatively, the patient's best corrected visual acuity (bcva) is 20/30 and the patient is doing well.The preoperative bcva was requested for comparison.
Additional Manufacturer Narrative
The micor extractor was discarded by the customer at the time of the event and is not available for evaluation.The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported event.The surgeon attributed the event to a post-occlusion surge when extracting the final piece of nucleus.The device labeling identifies capsular rupture as an inherent safety risk.The manufacturer has reviewed the event in the context of internal complaint data and postmarket surveillance.Based on currently available information, the reported rate of capsular tears and vitreous loss associated with the device remains very low and is below the rates reported in the literature and postmarket data for other legally marketed devices in the same product code.This conclusion is based on internal postmarket surveillance trend analysis and literature review.The manufacturer will continue to monitor for any emerging trends.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: 22693129
• Report Number: 3012123033-2025-00002
• Device Sequence Number: 8306649
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/01/2025

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: 04/27/2026
• Device Model Number: FG-50621
• Device Lot Number: FG25021810
• 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: 07/02/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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: FEMTOSECOND LASER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female