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

Model Number FG-50621

Device Problem Use of Device Problem (1670)

Patient Problem Capsular Bag Tear (2639)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection and functional testing.There was no damage or device malfunction identified and the device met specifications and performed as intended.The published literature was reviewed for comparison of the functional test results for occlusion response; the investigation data shows the device operates within the same expected ranges for similar marketed phacoemulsification devices.The surgical video was provided to the manufacturer for review and the following summary represents the medical review by the company medical affairs director / ophthalmologist.Cataract extraction was completed.As the spatula was removed from the secondary incision aqueous fluid leaked out of the incision and resulted in an unstable anterior chamber.Within 10 seconds, a posterior capsular tear occurred near the 10 - 12 o'clock position.At the time of the tear the micor extractor was positioned near the center cortex and the throttle was still engaged.There was no evidence of anterior chamber collapse and no vitreous fluid loss.The unstable anterior chamber made the capsular bag more susceptible to damage.As with any cataract surgery, caution should be exercised to control aspiration speed when there is evidence of chamber instability.These findings are consistent with the surgeon's assessment that "chamber instability" caused or contributed to the posterior capsule tear.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.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).

Event Description

A patient underwent cataract surgery in the right eye on (b)(6) 2023 where the micor lens fragmentation system (extractor and drive) was used to remove the cataractous lens fragments.Immediately following lens extraction with the micor extractor there was anterior chamber fluctuation (ac shallowing) and the posterior capsule tore.There was no vitreous loss and the planned intraocular lens was implanted.Preoperatively, the patient's best corrected visual acuity (bcva) in the operative eye was 20/50, improving to 20/30 one week postoperatively.At this one-week postoperative visit the patient was reported as stable and improving with 1+ corneal edema that was resolving.

Manufacturer Narrative

The surgical video was sent to an ophthalmologist for a second medical opinion.After review of the video, the physician concluded that the posterior capsule may have been compromised earlier than first thought (~minute 3:29-3:32) due to motion of the lens fragments contacting the capsule.The tip of the micor extractor cannula was in the correct position.The findings and conclusions codes remain unchanged.Manufacturer's reference #: (b)(4).

• Brand Name: MICOR LENS FRAGMENTATION SYSTEM
• Type of Device: 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: 17505268
• MDR Text Key: 320854046
• Report Number: 3012123033-2023-00004
• 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: K222236
• 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,Followup
• Report Date: 09/22/2023

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: 12/05/2023
• Device Model Number: FG-50621
• Device Lot Number: FG23060701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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: SPATULA
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White