MAUDE Adverse Event Report: IANTECH, INC. MILOOP LENS FRAGMENTATION DEVICE; OPHTHALMIC HOOK

Model Number FG-11881

Device Problem Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); Foreign Body In Patient (2687)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

The device was returned to iantech, decontaminated, and subjected to visual inspection and mechanical functional testing.The visual inspection revealed no damage and the device performed as expected.The reported problem could not be reproduced and the cause of the event remains undetermined.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.Capsular bag damage and dropped nuclear fragments are inherent risks of cataract surgery.[reference: schaal s, nesmith blw, ihnen ma, al-latayfeh m.Current medical and surgical management of retained lens fragments after cataract extraction.Us ophthalmic review 2014;7(2):95-99].(b)(4).

Event Description

A patient underwent cataract surgery on (b)(6) 2018 where the miloop device was used to section the cataractous lens into fragments.During the procedure the loop was partially deployed when the remainder of the loop deployed unexpectedly.The surgeon retracted and redeployed the loop ensuring the entire loop was under the capsulorhexis.The loop was then rotated past the midline, returned to midline and bisected and the distal nucleus prolapsed slightly.A second instrument was used to free the loop and rotate the nucleus.The surgeon noticed that the distal nucleus was still tilted up and the proximal still down in the bag and the nucleus was moving around too much and a decision was made to remove the miloop from the eye, at which time clear fluid (believed to be vitreous fluid) was observed on the loop.The surgeon proceeded with phacoemulsification and 2/3 of way through the procedure there was vitreous loss (from a posterior capsular bag tear) and a lens fragment dislocated into the vitreous.A vitrectomy was performed and an anterior chamber intraocular lens was implanted and the incision was sutured.The patient was referred to a retina specialist for retrieval of the dropped nuclear fragment.Additional information is being requested.

Event Description

The following additional information was provided by the surgeon.Preoperatively, the patient's best corrected visual acuity (bcva) in the operative (left) eye was 20/40-.The capsular bag damage consisted of: posterior capsule tear, zonular tear, vitreous loss, and dropped nucleus fragment.A pars plana vitrectomy was performed on (b)(6) 2018 and there was no sequelae from the dropped nuclear fragment.The patient's bcva improved to 20/25- at last examination on (b)(6) 2018 and the prognosis is good.Suture removal should reduce astigmatism and the surgeon expects the patient's vision and corneal surface to continue to improve.

Manufacturer Narrative

As reported in the initial report, the device evaluation findings demonstrated that the device performed as expected and no device malfunction was identified.The cause of the event remains undetermined.Capsular rupture is listed in the device labeling as an inherent risk of endocapsular lens fragmentation.(b)(4).

• Brand Name: MILOOP LENS FRAGMENTATION DEVICE
• Type of Device: OPHTHALMIC HOOK
• Manufacturer (Section D): IANTECH, INC.; 8748 technology way; reno NV 89521
• MDR Report Key: 7875286
• MDR Text Key: 120241127
• Report Number: 3012123033-2018-00007
• Device Sequence Number: 1
• Product Code: HNQ
• 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: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2019
• Device Model Number: FG-11881
• Device Lot Number: FG20180326-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPHTHALMIC INSTRUMENT (NOT SPECIFIED); PHACOEMULSIFICATION EQUIPMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR