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

Model Number FG-50621

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Vision (2139); Capsular Bag Tear (2639); Foreign Body In Patient (2687)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

The micor extractor was returned to the manufacturer for evaluation and subjected to microscopic visual inspection, dimensional inspection, and functional testing.There was no evidence of a device malfunction.The device met specifications and functioned as intended.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.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.Although a definitive reason for the tear has not been established, the patient's advanced dense cataract and compromised visibility from floppy iris syndrome likely predisposed the event, which is an inherent surgical risk of endocapsular lens fragmentation.The micor drive and miloop devices used during the procedure are not suspected as causing or contributing to the event.The device labeling identifies capsular rupture as a safety risk.Manufacturer's reference #: (b)(4).

Event Description

An (b)(6) -year-old male patient underwent cataract surgery on (b)(6) 2021 where the miloop and micor lens fragmentation system (extractor and drive) were used to fragment and (partially) remove the cataractous lens.The patient's posterior capsule tore during surgery and a lens fragment dropped into the vitreous cavity; the cataract surgery was unable to be completed.The tear occurred while using the micor extractor and prior to implantation of an intraocular lens (iol).The surgeon described the event as "small pupil, floppy iris, bag tear; nucleus fragment dropped".In addition, a handwritten note was returned with the micor extractor stating: "lens dropped.Poor eye health.No device defect.No product complaint." the surgical video revealed the following additional information and insight.The miloop was used to bisect the patient's grade 4 cataractous lens.Intraoperative floppy iris syndrome obstructed visibility and open access to the cataract.The miloop procedure was executed properly, resulting in 4 lens quadrants; no issues were observed and there was no damage to the capsular bag until well after the miloop portion of the surgery had been completed.When the surgeon depressed the micor throttle at the center of the cortex in the iris plane, the floppy iris migrated towards the distal tip of the micor extractor, blocking aspiration of the cataract tissue.The surgeon restrained the iris using iris retractors and continued to extract the cataract.After half of the lens had been removed, the surgeon observed a tear in the posterior capsule.The micor tip placement was correctly centered throughout the entire procedure leading up the capsule tear; there was no evidence of user error or device malfunction.The iris retractors were in place prior to the tear.The surgeon moved the remaining cortical material to the periphery to attempt to maintain the fragments in the anterior chamber.Less than 2 minutes after the tear (and while the surgeon was attempting to remove smaller lens fragment), a larger lens segment inadvertently dropped into the vitreous cavity.It is unclear exactly how or when the posterior capsule tore.The patient's preexisting poor eye health (dense/advanced cataract, floppy iris, small pupil) likely predisposed the event.There was nothing unusual about the micor procedure that leads to a direct causal relationship.The cataract procedure was discontinued and requires secondary surgical intervention (referral to retina specialist to address the retained lens fragment) and subsequent implantation of an intraocular lens.Additional information has been requested from the surgeon.

Manufacturer Narrative

Manufacturer's reference#: (b)(4).

Event Description

The surgeon provided the following additional patient information.The patient has severe age-related macular degeneration in the operative eye.The patient's preoperative visual acuity was count fingers (cf) at 1 foot.Postoperatively, the patient's uncorrected distance visual acuity (ucdva) was 20/200 and best corrected distance visual acuity (bcdva) was 20/70-2.His postoperative best corrected near visual acuity (bcnva) was j10.

• 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
• MDR Report Key: 12524060
• MDR Text Key: 281742573
• Report Number: 3012123033-2021-00010
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (y/n): N
• PMA/PMN Number: K200584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: FG-50621
• Device Lot Number: FG21043001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IRIS RETRACTOR.; MICOR DRIVE.; MILOOP.
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR