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 10/19/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user 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.Additional "informaiton" has been requested from the surgeon, but the preliminary information suggests the event was attributed to unexpected patient movement during the procedure.Capsular bag damage is an inherent risk of cataract surgery.Manufacturer's reference #: (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.As the surgeon was preparing to bisect the lens the patient moved unexpectedly, resulting in a posterior capsule tear.There was no vitreous loss, no vitrectomy was performed, and a 3-piece intraocular lens was implanted in the sulcus.Additional information has been requested.

• 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: 8074090
• MDR Text Key: 127256203
• Report Number: 3012123033-2018-00009
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Model Number: FG-11881
• Device Lot Number: FG20180411-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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
• Patient Outcome(s): Required Intervention