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

Model Number FG-11881

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643); Foreign Body In Patient (2687)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the facility and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.There was no report of a device malfunction.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 surgeon used a second instrument to facilitate rotation of the lens for the second miloop cut.After the second cut was made, the capsular bag ruptured posteriorly and a lens fragment dislocated into the vitreous cavity.The patient was referred to a retina specialist for intervention to address the dropped nuclear fragment.The surgeon reports that the patient is doing well postoperatively.Additional information is being requested.

Manufacturer Narrative

In the surgeon's opinion, the posterior capsule tear was related to use of the device where the lens dropped after removing the first lens fragment.No other devices had been in proximity to the posterior capsule.(b)(4).

Event Description

The following additional information was provided by the surgeon.The operative eye was the left eye and during lens fragmentation the posterior capsule tore, resulting in vitreous loss and dropped nucleus.A vitrectomy was performed and a posterior chamber intraocular lens was implanted in the sulcus with optic capture.The patient was referred to a retina specialist who performed a trans pars plana vitrectomy on (b)(6) 2018.The patient's best corrected distance visual acuity (bcdva) decreased from 20/40- preoperatively to 20/60-1 at last examination on (b)(6) 2018 and the patient is reported as stable.

• 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: 7848850
• MDR Text Key: 119324277
• Report Number: 3012123033-2018-00006
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• 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?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPHTHALMIC INSTRUMENT (NOT SPECIFIED)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR