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

Model Number FG-11881

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

The device was returned to iantech and examined upon receipt; a small bump was observed on the outside of the carton where the device appeared to have moved forward during shipment.The device was subsequently decontaminated and subjected to visual inspection, which revealed damage to the wire housing tube, which was bent out of shape (likely from impact).The damage is believed to be the result of impact sustained during transit.Review of the surgical video provided by the surgeon confirmed there was no observable device damage at the time of surgery.The condition of the returned device precluded thorough mechanical functional testing, however the device was opened and visually inspected and no anomalies were observed.Review of the surgical video (miloop excerpt provided) did not yield any root cause information and the complete surgical video was requested.The cause of the capsular tear remains unknown at this time.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 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.During the procedure the surgeon noted some friction associated with slider actuation.Limited information was provided regarding the surgical details, however, a posterior capsule rupture occurred.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: 7848558
• MDR Text Key: 119325020
• Report Number: 3012123033-2018-00005
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2018

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: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• 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
• Patient Outcome(s): Required Intervention