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

Model Number FG-50621

Device Problem Use of Device Problem (1670)

Patient Problems Corneal Edema (1791); Eye Injury (1845)

Event Date 10/02/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 327126749
• Report Number: 3012123033-2023-00005
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White