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

Model Number	FG-50621
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); Foreign Body In Patient (2687)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection, functional testing, and then disassembled for internal inspection.There was no damage or device defect identified and the device met specifications.The device had dried viscoelastic present inside the cutter tube (normal use condition) that prevented the device from aspirating during functional testing.There was no alleged malfunction and no device malfunction identified during the device evaluation.This conclusion is consistent with the event reported by the surgeon who attributed the capsular tear and sequelae to the surgical technique employed, which placed additional pressure on the posterior capsule and compromised the integrity.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.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).
Event or Problem Description
A 71-year-old patient underwent cataract surgery on (b)(6) 2023 where the micor lens fragmentation system (extractor and drive) was used to remove the cataractous lens.The patient's posterior capsule tore during surgery.The tear occurred while using the micor extractor during removal of the lens epinucleus.There was vitreous fluid loss and the lens dropped into the vitreous cavity.An anterior vitrectomy was performed and no intraocular lens was implanted.The patient was referred to a retina specialist to address the dropped nucleus and implant a sulcus-fixated intraocular lens.At the one-day postoperative visit, the patient's best corrected visual acuity was 20/25.Additional information was requested from the surgeon which revealed the cause was attributed to surgical technique where an aggressive vertical-chop technique was employed.There were no device performance problems with the micor system.

• 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 ; 9255959817
• MDR Report Key: 16969743
• Report Number: 3012123033-2023-00001
• Device Sequence Number: 12125671
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222236
• 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): 05/19/2023

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: 09/27/2023
• Device Model Number: FG-50621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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: 71 YR
• Patient Sex: Unknown