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

Model Number	FG-50621
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); Foreign Body In Patient (2687)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.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.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 left eye on (b)(6) 2024 where the micor lens fragmentation system was used to remove the cataractous lens fragments.The cataract surgery was performed in combination with implantation of a glaucoma drainage device (gdd) where the gdd was implanted prior to lens extraction.The cataract was described as hard and the pupil was very constricted.During lens removal with the micor extractor the posterior capsule tore and there was vitreous loss and a portion of the lens dropped into the vitreous cavity.A vitrectomy was performed and the patient was referred to a retina specialist.No intraocular lens was able to be implanted due to lack of capsular support.Postoperatively the patient had corneal edema and inflammation.Intraocular lens implantation will be performed as the eye heals.

• 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: 20584920
• Report Number: 3012123033-2024-00010
• Device Sequence Number: 21039681
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/31/2024

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: 06/29/2025
• Device Model Number: FG-50621
• Device Lot Number: FG24042901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: Required Intervention; Disability
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American