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 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user facility 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 a combination of patient movement during the procedure and a very dense cataract with weak zonules, which predisposed the patient, and a lack of insurance coverage for general anesthesia which was warranted for the dense cataract.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 with a very dense cataract and weak zonules underwent cataract surgery on (b)(6) 2018 where the leep device was used to section the cataractous lens into fragments.The surgeon requested general anesthesia because of the dense cataract and anticipated procedure length, but the insurance company only covered local anesthesia.During the procedure while the surgeon was bisecting the nucleus and retracting the loop, the patient abruptly moved his head and the loop of the leep device inadvertently caught the capsulorhexis and caused a rent.The surgeon attempted to mitigate the damage, but the capsular tear extended during phacoemulsification and secondary surgical intervention was required (extracapsular cataract extraction with a vitrectomy) and a 3-piece intraocular lens was implanted.The patient's postoperative best corrected visual acuity (bcva) is 20/50.

• 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: 7571785
• MDR Text Key: 110164315
• Report Number: 3012123033-2018-00003
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: FG-11881
• Device Lot Number: FG20171201-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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: 92 YR