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

Model Number	FG-50621
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device identifiers were available; however, the micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection and functional testing, which consisted of flow, vacuum, surge, and cutter testing.There was no damage or device malfunction identified and the device met specifications and performed as intended.The surge testing with an artificial eye revealed the pressure drop was within specification.The surgeon believes the patient's ocular history (same event in fellow eye) likely caused or contributed to the event, but there were early comments from the surgeon potentially implicating the miloop and/or the micor as contributing factors.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).
Event or Problem Description
A patient with a dense cataract and weak zonules underwent cataract surgery in the right eye on (b)(6) 2024 where the miloop and micor lens fragmentation system were used to fragment and remove the cataractous lens fragments.The miloop was used to section the lens into 4 quadrants.The micor extractor was then used to remove 2 quadrants, after which time the presence of zonular dialysis became evident.The remaining 2 quarters of the cataractous lens descended posteriorly through a posterior capsular tear and into the vitreous cavity.The exact timing of the zonular/capsular tear is not known, but the surgeon stated the damage occurred during lens fragmentation and reported a post-occlusion surge during micor.Patient follow-up information was requested from the surgeon.Additional follow-up was provided by the surgeon on july 18, 2024, who reports the patient was doing well and there has been no sequelae and no adverse impact on vision.A retina specialist was available and intervened during the initial surgery; a pars plana vitrectomy was performed and the fallen lens fragments were removed from the vitreous.A different 3-piece intraocular lens model was implanted.At the patient's last visit on july 9, 2024, bcva improved to 20/50 (compared to 20/200 preoperatively).The patient had a relevant history of zonular weakness and a dropped nucleus during cataract surgery in the fellow eye.The patient has had multiple retinal procedures in both eyes by the same retina specialist who completed this case.

• 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: 19822648
• Report Number: 3012123033-2024-00004
• Device Sequence Number: 21006225
• 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): 07/24/2024

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 Model Number: FG-50621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MILOOP
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White