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

Model Number	FG-50621
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/07/2024
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 identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).
Event or Problem Description
A patient underwent cataract surgery in the right eye on (b)(6) 2024, where the micor lens fragmentation system was used to remove the cataractous lens fragments.The capsular bag ruptured while attempting to remove the epinucleus shell with the micor extractor tip.The intraocular lens was able to be implanted in the capsular bag and there was no vitreous prolapse.The surgeon attributed the capsular damage to the micor extractor tip.At the one-day postoperative visit the cornea was clear.The surgeon does not anticipate any long-term sequelae.Additional patient follow-up was provided by the surgeon on may 30, 2024 who reports the patient is doing well.At the patient's last visit on may 30, 2024, iop improved and visual acuity remained stable.Refer to b6 for details.The patient is scheduled for next follow-up on july 11, 2024.

• 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: 19492233
• Report Number: 3012123033-2024-00003
• Device Sequence Number: 15649828
• 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): 06/06/2024

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: 05/21/2025
• Device Model Number: FG-50621
• Device Lot Number: FG24032201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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: Disability
• Patient Age: 68 YR
• Patient Sex: Female