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

Model Number FG-50621

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Date 06/14/2023

Event Type  Injury  

Event Description

A 71-year-old female patient underwent cataract surgery in the left eye on (b)(6) 2023 where the micor lens fragmentation system (extractor and drive) was used to remove the cataractous lens fragments.During the micor procedure there was anterior chamber fluctuation and the posterior capsule tore which resulted in vitreous fluid loss.A vitrectomy was performed and a 3-piece intraocular lens was implanted in the sulcus.Preoperatively, the patient's best corrected visual acuity (bcva) was 20/25.Postoperatively, the patient's bcva improved to 20/20 and the patient was reported as doing well.

Manufacturer Narrative

The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection, functional testing, then disassembled for internal inspection.There was no damage or device malfunction identified and the device met specifications and performed as intended.The published literature was reviewed for comparison of the functional test results for forced occlusion response; the investigation data shows the device operates within the same expected ranges for similar marketed phacoemulsification devices.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).

• 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: 17329610
• MDR Text Key: 319182083
• Report Number: 3012123033-2023-00003
• 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: 07/14/2023

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: 11/15/2023
• Device Model Number: FG-50621
• Device Lot Number: FG23051801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American