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

Model Number	FG-50621
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
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 surgeon experienced a small hole in the posterior capsule during irrigation and aspiration of cortex.The anterior hyaloid remained intact and there was no vitreous fluid loss.Surgical technique was employed appropriately, i.E., not allowing capsular bag to bow forward.The surgeon attributed the event to the micor device citing "snappiness" which is further clarified below."while the event was attributable to the fluidics of the device, the fact that the [micor extractor] tip does not have sharp edges also contributed to the small size of the hole, the fact that the tear did not extend, and my ability to place a one piece toric multifocal iol in the bag as planned.There was a thin epinuclear plate [of the cataract] present.In both phaco[emulsification] and micor, when you reach for a thin remaining piece, there is a risk of the device building vacuum and popping through the remaining [cataract] piece and then interacting with the posterior capsule, thereby causing a tear.There was a clinical decision made to reach for the remaining thin piece that contributed to the adverse event.While i attribute the quick build in vacuum to the device, the adverse event was also attributable to surgeon clinical decision making.On the other hand, i can say with absolute confidence that if a similar situation had occurred with phaco (pc tear from reaching for an epinuclear piece), that the sequelae would have been very different, and worse.Whenever the phaco needle creates a pc [posterior capsule] tear, the hole has jagged edges and so it immediately expands under the high flow state.With micor, the hole seems to never expand because of the very smooth edges and the low flow of irrigation.Had i been using phaco, the patient would have ended up with a 3-piece monofocal iol [intraocular lens] in the sulcus, despite having paid for a premium iol.Because of the nature of the pc tear, i was still able to place a single piece multifocal toric iol in the bag.I've never been able to save a similar situation to this with phaco like i did.My presumption is that it was the micor's other features (low flow and smooth tip edges) that made a very good situation out of an adverse event.".
Additional Manufacturer Narrative
The micor extractor was discarded by the customer at the time of the event and is not available for evaluation.No device identifiers are available.The surgeon provided their medical opinion in section b5 describing the factors that may have caused or contributed to the event.While the device was not available for testing, based on review of the device design history file, 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).

• 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: 20164644
• Report Number: 3012123033-2024-00008
• Device Sequence Number: 7363503
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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 Model Number: FG-50621
• 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: 08/09/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 79 YR
• Patient Sex: Unknown
• Patient Race: White