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

Event Date 08/07/2017

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 manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.The event was attributed to patient movement during the procedure and there was no report of a device malfunction.Capsular bag damage and vitreous loss is an inherent risk of cataract surgery.(b)(4).

Event Description

A patient underwent cataract surgery in the right 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 nucleus fragmentation, after which the leep device was introduced into the eye.While the leep was in the eye and prior to making the first retraction, the patient raised her head unexpectedly.There were no other device in the eye at the time of patient movement.The leep was retracted from the eye and the surgeon proceeded with lens removal.When the first quadrant was removed it was discovered that the posterior capsule had torn and vitreous fluid was present.A vitrectomy was performed and the intraocular lens was implanted without incident.Postoperatively the patient is stable and there is no adverse impact on the patient's vision and no sequelae.The surgeon attributed the capsular tear to patient movement during closure of the leep.

• 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: 7130883
• MDR Text Key: 95322614
• Report Number: 3012123033-2017-00004
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: FG-11881
• Device Lot Number: FG20170605-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• 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: 77 YR