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

Model Number FG-11881

Device Problem Insufficient Information (3190)

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

Event Date 09/05/2018

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 cause of the event remains undetermined; however, the surgeon believes the miloop pierced the posterior capsule (presumably during patient movement).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.] manufacturer's reference #: (b)(4).

Event Description

A patient underwent cataract surgery in the left eye on (b)(6) 2018 where the miloop device was used to section the cataractous lens into fragments.During the procedure the patient unexpectedly moved his eye upwards; the surgeon moved along with the patient to keep the cannula centered, then rotated the miloop and bisected the lens.The patient then returned his eye to a neutral position and the surgeon redeployed the miloop.A second instrument was used to rotate the nucleus within the loop and the lens was bisected and the miloop was removed from the eye.The surgeon proceeded with phacoemulsification and suspected a capsule tear because the lens segments were not coming up to the phaco tip as expected, and the surgeon used a second instrument to aid in retrieving the lens segments.Once the nucleus was removed a tear was observed in the posterior capsule, there was vitreous loss, and a small lens fragment dislocated into the vitreous.A vitrectomy was performed, the lens fragment was removed from the vitreous, and an anterior chamber intraocular lens was implanted.Follow-up was requested and the surgeon provided the following additional information.The patient was referred to a retinal specialist and is currently under observation.The event resulted in uveitis and glaucoma (note: the patient had a history of glaucoma).The patient's best corrected visual acuity (bcva) decreased from 20/70 preoperatively to counting fingers (cf) 2 weeks postoperatively and the patient's prognosis is guarded.

• Brand Name: MILOOP LENS FRAGMENTATION DEVICE
• Type of Device: OPHTHALMIC HOOK
• Manufacturer (Section D): IANTECH, INC.; 8748 technology way; reno NV 89521
• Manufacturer (Section G): IANTECH, INC.; 8748 technology way; reno NV 89521
• Manufacturer Contact: jane demkovich ; 8748 technology way; reno, NV 89521 ; 7754731014
• MDR Report Key: 7926857
• MDR Text Key: 122372207
• Report Number: 3012123033-2018-00008
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2019
• Device Model Number: FG-11881
• Device Lot Number: FG20180328-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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: OPHTHALMIC INSTRUMENT (NOT SPECIFIED); PHACOEMULSIFICATION EQUIPMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR