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

Model Number FG-11881

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

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 10/10/2017

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 number and there were no discrepancies or unusual findings that relate to the reported event.The patient's preexisting advanced cataract was a significant contributing factor and there was no report of a device malfunction.Capsular bag damage and vitreous loss are inherent risks of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A patient with a dense 4+ brunescent 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.At some point during the phacoemulsification procedure the posterior capsule tore and resulted in vitreous loss.The event required secondary surgical intervention to perform a vitrectomy and intraocular lens (iol) implantation was deferred for one week when a scleral-fixated iol was implanted without incident.There was no adverse impact on the patient's vision and no sequelae.The surgeon attributed the event to the patient's advanced cataract.The patient was examined 3 months postoperatively and the patient was doing well with improved vision.

• 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: 7214159
• MDR Text Key: 98043885
• Report Number: 3012123033-2018-00001
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: FG-11881
• Device Lot Number: FG20170516-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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
• Patient Age: 72 YR