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

Model Number FG-11881

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

Patient Problem Capsular Bag Tear (2639)

Event Date 08/06/2018

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, but the surgeon suspects that patient anatomy (possible adhesion) may have been a contributing factor.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 and the evaluation findings revealed no device defect.Capsular bag damage is an inherent risk of cataract surgery.(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 surgeon was unable to rotate the loop around the nucleus.The surgeon retracted the loop and cut off a lens portion from the side then proceeded to the phacoemulsification portion of the procedure.The surgeon noted that the capsular bag was floppy and after phacoemulsification the surgeon observed a diagonal posterior capsular tear, but there was no vitreous loss.A three-piece intraocular lens was implanted without incident.The surgeon suspects there may have been an adhesion that caught the loop and pulled the bag, possibly precipitating the capsular tear.

• 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: 7845090
• MDR Text Key: 119151362
• Report Number: 3012123033-2018-00004
• 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: 09/04/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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: PHACOEMULSIFICATION EQUIPMENT
• Patient Outcome(s): Required Intervention