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

Model Number	FG-50621
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The micor extractor was discarded by the customer at the time of the event and is not available for evaluation.No device identifiers are available.The patient's preexisting condition (dense cataract and weak zonules) likely contributed to the event.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).
Event or Problem Description
A patient with a dense white cataract (grade 3+ or 4), weak zonules, and a deep eye underwent cataract surgery in the right eye on (b)(6) 2025.The surgeon reported experiencing difficulty during lens segmentation and chopping due to the cataract density.The micor lens fragmentation system was then used to remove the cataractous lens fragments.A manual instrument was used to manipulate one of the segments into the anterior chamber and cataract extraction continued fairly efficiently considering the density.When working on the last lens segment, the surgeon made the decision to convert to phacoemulsification.Viscoelastic was injected and 2 capsular hooks were used for the remainder of the procedure and a capsular tension ring was inserted to stabilize the capsule.At some point during lens extraction there was a small capsular tear, but there was no vitreous fluid loss and no vitrectomy was needed.The original intraocular lens plan was to implant a toric iol in the capsular bag; however, a 3-piece intraocular lens was implanted in the sulcus (which was described as fixated strongly and centered perfectly).In order to address the change in iol model, limbal relaxing incisions were made to address the patient's preexisting astigmatism.

• 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: 22354520
• Report Number: 3012123033-2025-00001
• Device Sequence Number: 15629680
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/28/2025

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 Model Number: FG-50621
• 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: 05/28/2025
• Initial Report FDA Received Date: 06/30/2025
• 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: MANUAL SURGICAL INSTRUMENT; PHACOEMULSIFICATION EQUIPMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown