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

Model Number	FG-50621
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The micor extractor was discarded by the user facility and is not available for evaluation.The 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 miloop and micor drive devices used during the procedure are not suspected as causing or contributing to the event.Surgical video was provided to the manufacturer for review.Video footage reviewed by company personnel (medical and engineering) did not reveal any evidence of a device malfunction.The device labeling identifies capsular rupture as a safety risk.(b)(4).
Event or Problem Description
A (b)(6) patient underwent cataract surgery on (b)(6) 2021 where the miloop and micor lens fragmentation system (extractor and drive) were used to fragment and remove the cataractous lens.The patient's posterior capsule tore during surgery.The surgical video revealed the following additional information and insight.The miloop was used to bisect the patient's grade 3 cataractous lens.There were no problems with the technique used to execute the miloop procedure.There was no evidence of a device malfunction with the miloop or micor devices.There was a small rent in the posterior capsule at minute 2:57; at this time the micor extractor was in use and the spatula was positioned in the area of the tear.At minute 3:06 a lens fragment rotated within the capsule and at 3:21 the tear expanded, increasing to a larger tear by 3:33.The surgeon appeared to proceed with intraocular lens implantation, but this portion of the surgery was not recorded.The final conclusion of the expert video analysis revealed no clear etiology.Patient follow-up has been requested from the surgeon on several occasions, but no response has been received.

• Brand Name: MICOR LENS FRAGMENTATION SYSTEM
• Common Device Name: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.; 8748 technology way; reno NV 89521
• Manufacturer (Section G): CARL ZEISS MEDITECH CATARACT TECHNOLOGY, INC.; 8748 technology way; reno NV 89521
• Manufacturer Contact: andy rybold ; 8748 technology way; reno, NV 89521 ; 9255959817
• MDR Report Key: 12848608
• Report Number: 3012123033-2021-00017
• Device Sequence Number: 11820375
• 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: K200584
• 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): 11/19/2021

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: 11/06/2021
• Device Model Number: FG-50621
• Device Lot Number: FG21050401
• 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: 10/28/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2021
• 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: MICOR DRIVE; MILOOP; SPATULA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown