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

Model Number FG-11881

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user and is not available for evaluation.The event was solely attributed to use error and there was no device malfunction.Capsular bag damage is an inherent risk of cataract surgery.The device history records were reviewed for this lot number and there were no discrepancies or unusual findings that relate to the reported event.(b)(4).

Event Description

A patient with a moderately advanced senile cataract underwent cataract surgery in the left eye on (b)(6) 2017 where the leep device was used to section the cataractous lens into fragments.During surgery, a femtosecond laser was used for the capsulotomy and nucleus fragmentation, after which the leep device was introduced into the eye and nucleus engagement was initiated.During this portion of the procedure the iris constricted causing extremely limited visibility and there was a substantial amount of proximal-distal motion during retraction of the cutting loop and removal.At some point during the phacoemulsification procedure and phaco tip chopping it was observed that the posterior capsule had ruptured.The event required secondary surgical intervention to perform an anterior vitrectomy and remove the lens fragments from the anterior chamber.A three-piece intraocular lens was implanted without incident.There was no adverse impact on the patient's vision and no sequelae.The surgeon was unable to attribute the capsular damage to one specific device and stated that use of any of the concurrent devices (femtosecond laser, phacoemulsification equipment, or the leep) may have caused or contributed to the event.

• 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: 7062209
• MDR Text Key: 93030233
• Report Number: 3012123033-2017-00002
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: FG-11881
• Device Lot Number: FG20170828-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2017
• 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
• Patient Outcome(s): Required Intervention