MAUDE Adverse Event Report: IANTECH, INC. LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE; OPHTHALMIC HOOK

Model Number FG-11881

Device Problem Use of Device Problem (1670)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user and is not available for evaluation.The device history records were reviewed for this lot and there were no discrepancies or unusual findings that relate to the reported event.The surgeon attributed the event to part of the learning curve for a new device.There was no report of a device malfunction.Capsular bag damage and vitreous loss are inherent risks of cataract surgery.(b)(4).

Event Description

A patient underwent cataract surgery on (b)(6) 2017 where the leep device was used to section the cataractous lens into fragments.During the procedure the posterior capsule tore and resulted in a loss of vitreous fluid.The event required secondary surgical intervention to address the vitreous loss and perform deferred intraocular lens implantation with an anterior chamber lens.The patient's postoperative visual acuity is 20/20.The surgeon attributed the event to the learning curve with a new device.Additional information is being requested.

• Brand Name: LOW ENERGY ENDOCAPSULAR PHACO (LEEP) 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: 7315967
• MDR Text Key: 101578852
• Report Number: 3012123033-2018-00002
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: FG-11881
• Device Lot Number: FG20170919-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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