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

Model Number FG-50621

Device Problem Insufficient Information (3190)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

The micor extractor and miloop devices were discarded by the facility and are 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.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.Surgical video was provided to the manufacturer for review.Video footage reviewed by company personnel did not reveal any evidence of a device malfunction with the micor extractor.Review of the information available revealed no clear etiology.The device labeling identifies capsular rupture as a safety risk.Manufacturer's reference #: (b)(4).

Event Description

A (b)(6) patient underwent cataract surgery in the left eye on (b)(6) 2022 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 tear occurred while using the micor extractor during removal of lens nucleus when the remaining lens fragments were moving around in the capsular bag.The tear resulted in loss of vitreous fluid which required an anterior vitrectomy; a 3-piece intraocular lens was implanted in the sulcus.The micor extractor and miloop devices were disposed of by the facility, but a video recording of the surgery was provided.The surgical video revealed the following additional information and insight.The patient had a grade 1+ cataract.The miloop was used to bisect the lens.It was noted on the first attempt to bisect that the lens prolapsed forward.During lens extraction using the micor extractor, the tip of the device was positioned in center of the cortex and throttle input was approximately 50% at the time of the posterior capsular bag capture.The surgeon then used the vacuum break feature to release the captured bag.There was no evidence of device malfunction with the micor device.Based on video evidence, the tear likely occurred at minute 6:58 near the position of the micor extractor tip and ophthalmic hook (manufacturer unknown).The final conclusion of the expert video analysis revealed no clear etiology.Patient follow-up has been requested from the surgeon on two separate occasions, but no response has been received.

• Brand Name: MICOR LENS FRAGMENTATION SYSTEM
• Type of Device: 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: 14308163
• MDR Text Key: 290973389
• Report Number: 3012123033-2022-00001
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: FG-50621
• Device Lot Number: FG22020401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICOR DRIVE; MILOOP; OPHTHALMIC HOOK
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR