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

Model Number FG-50608

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Capsular Bag Tear (2639); Foreign Body In Patient (2687)

Event Date 08/31/2021

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.The miloop device was discarded by the user facility and was not available for evaluation.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 with the miloop or micor devices.Although a definitive reason for the tear has not been established, the patient's advanced dense cataract and surgical technique likely predisposed the event, which is an inherent surgical risk of endocapsular lens fragmentation.The device labeling identifies capsular rupture as a safety risk.This mdr is for the miloop device.Refer to mdr # 3012123033-2021-00012 for the second device involved in this event.(b)(4).

Event 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 (partially) remove the cataractous lens.The patient's posterior capsule tore during surgery and a lens fragment dropped into the vitreous cavity.The tear occurred while using the micor extractor and prior to completing cataract lens extraction or implantation of an intraocular lens (iol).The surgical video revealed the following additional information and insight.The miloop was used to bisect the patient's grade 3+ cataractous lens.It was observed that the technique used to execute the miloop procedure was not performed in accordance with the labeled instructions for use.Specifically, the wire loop was not rotated fully around the cataract when the cut was made and the surgeon pushed the cataract to the left periphery using the miloop.The exerted peripheral pressure may have placed additional stress on the zonules.Although no damage to the capsular bag was observed until later in the case when the micor was being used and there was no alleged device malfunction, the use error with the miloop may have contributed to the adverse event.The exact time of the posterior capsular tear is not definitively known, but according to video evidence, it was first observed in the lower left quadrant while the micor extractor tip remained at the center position (correct positioning).At the time the tear was observed, the surgeon was actuating the throttle at the center of the cortex in the iris plane.Notably, the surgeon used a bimanual approach and the ophthalmic hook (inserted into the paracentesis) was the closest instrument to the tear and may have caused or contributed to the tear.The surgeon moved the remaining cortical material to the periphery to attempt to maintain the fragments in the anterior chamber.The micor tip placement was correctly centered throughout the entire procedure; there was no evidence of micor use error or device malfunction during cataract removal.Approximately 2 minutes later while attempting to remove smaller nuclear fragments, a small lens segment appeared to be visible in the vitreous cavity, but this finding was unconfirmed.Cortical cleanup was performed, the original incision was enlarged, and a sulcus-fixated iol was implanted.There was nothing unusual observed about the micor procedure that leads to a direct causal relationship for the adverse event.Patient follow-up was requested and the surgeon provided the following update on (b)(6) 2021.The patient's current postoperative visual acuities are as follows: uncorrected distance visual acuity (ucdva) 20/30; uncorrected near visual acuity (ucnva) j2; uncorrected intermediate visual acuity (uciva) 20/20; best corrected distance visual acuity (bcdva) 20/20 with manifest refraction (mr) -0.50 + 0.50 @ 10; best corrected near visual acuity (bcnva) j1+ (with + 1.25 add).

Manufacturer Narrative

Patient code (b)(6) (reported on the initial report) is no longer accurate.It is unlikely that the miloop contributed to the event.Conclusion codes 4315 and 18 (reported on the initial report) are no longer accurate.This mdr is for the miloop device.Refer to mdr # 3012123033-2021-00012 for the second device involved in this event.Manufacturer's reference #: (b)(4).

Event Description

The surgical video was sent to another ophthalmologist for expert analysis and the following new observations were made.The exact time of the capsular tear was identified at minute 3:36, which was during the micor portion of the procedure (and well after the miloop procedure).At the time of the tear, the micor extractor tip was positioned too close to the posterior capsule.Later in the case, a small nuclear fragment appeared to temporarily enter the vitreous cavity; however the fragment floated back up and was evacuated after iol implantation and did not end up being retained in the vitreous cavity.The final root cause of the capsule tear was attributed to inadvertent posterior placement of the micor extractor tip.The initial report of "lens fragment dropped into the vitreous cavity" was ruled out and is now consistent with the event as reported by the initial reporter.

• Brand Name: MILOOP LENS FRAGMENTATION DEVICE
• Type of Device: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.; 8748 technology way; reno NV 89521
• MDR Report Key: 12538016
• MDR Text Key: 280697496
• Report Number: 3012123033-2021-00011
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/28/2021

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
• Device Operator: Health Professional
• Device Model Number: FG-50608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICOR DRIVE.; MICOR EXTRACTOR.; OPHTHALMIC HOOK.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR