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	Corneal Edema (1791); Eye Injury (1845)
Date of Event	10/02/2023
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 and functional 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.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 provides the following relevant instruction: as aspiration occurs, gravity-fed irrigation will replace the fluid volume removed.Should the cutter tube inadvertently aspirate capsular bag, iris or other structure not desired, the vacuum break function can be activated to equalize the pressure in the cutting/aspiration tube and release the structure.This is achieved by placing finger under throttle and lifting.Following removal of the micor® extractor, the roller clamp may be closed to stop bss flow.Based on review of the device and the labeling, the root cause of the reported event was attributed to a combination of user error and patient anatomy.Manufacturer's reference # (b)(4).
Event or Problem Description
A patient underwent cataract surgery in the left eye on october 2, 2023 where the micor lens fragmentation system (extractor and drive) was used to remove the cataractous lens fragments.Iridodialysis occurred during micor use; the event required 6 clock degrees of iridodialysis repair.The surgeon noted that the patient had a small pupil and iris and a capsular tension ring was placed.Preoperatively, the patient's best corrected visual acuity (bcva) in the operative eye was 20/40 -1, decreasing to 20/60 +2 at the one-week postoperative visit.At this visit the patient was reported as healing appropriately with significant postoperative corneal edema.

• 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 89521 ; 7754731014
• MDR Report Key: 18052589
• Report Number: 3012123033-2023-00005
• Device Sequence Number: 6962454
• 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: 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): 11/01/2023

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: 02/05/2024
• Device Model Number: FG-50621
• Device Lot Number: FG23080901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White