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

Model Number	FG-50621
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/27/2024
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, 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 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 surgeon attributed the event to a dense lens.The micor system was designed to build vacuum to maximum potential in the same timeframe as phacoemulsification.However, the micor does not have a computer display and was not designed with indicators for metrics such vacuum level, fluidics, etc.Importantly, the user has the ability to break vacuum at any time during lens extraction to mitigate the risk of capsular bag damage.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.A miloop was used for segmentation of the lens.The miloop was inserted into the corneal incision and the surgeon made 2 cuts with the miloop to segment the lens into 4 quadrants.There were no problems with the miloop portion of the procedure and the capsule was intact at the time the miloop was removed from the eye.The micor extractor was then used for lens extraction.The cataract was described as dense.While removing the last fragment, the surgeon appears to engage the micor at full throttle and a post-occlusion surge is observed, which is immediately followed by a posterior capsular bag tear.Review of surgical video revealed the tip of the micor extractor engaged with the posterior capsule.There was no loss of vitreous fluid and no vitrectomy was performed.The surgeon continued and completed lens extraction and implanted a posterior chamber intraocular lens as planned.Postoperatively the patient had corneal edema and mild inflammation that was treated with steroids.There was no surgical intervention, no change to the surgical plan, no decrease in best corrected visual acuity (bcva), and no sequelae.At the most recent visit 1-month postoperatively the patient's status and prognosis was reported as very good.

• 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: 20584934
• Report Number: 3012123033-2024-00009
• Device Sequence Number: 18273079
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• 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): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MILOOP.
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American