MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Sticking (1597)

Patient Problems Corneal Abrasion (1789); High Blood Pressure/ Hypertension (1908)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in the lot.The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information was requested and received.(b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implantation procedure, the trailing haptic became caught in the injector and tore off during the insertion of the lens into the eye.With difficulty and extended time the lens was cut and removed from the eye and another lens was implanted.Due to the extended time required for event management, the patient's blood pressure increased and the his cornea was scratched due to frequent eye movements.The surgeon felt the use of the device was stressful due to many "check points" during use.In a follow up, the surgeon indicated that the corneal endothelial cell issue was not serious and patient was recovering.Additional data was provided indicating that the planned percentage use of a glucocorticoid medication was increased from.01% to.1% due to the event.The patient's vision increased from.2 (20/100) to.7 (20/30) within the first postoperative week.

Manufacturer Narrative

The device and the lens were returned separated.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been fully advanced outside of the nozzle tip.A piece of the broken haptic is observed pinned on top of the plunger.The lens was returned wrapped in gauze.Viscoelastic is observed on the lens.One haptic is broken-gusset and distal area (distal portion in device).The lens has been cut into three pieces.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the broken haptic could not be determined.The broken haptic portion is on top of the plunger pinned against the upper tip area.The position of the broken haptic portion indicates it was not in a proper position for advancement per the provided diagrams in the dfu.(b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7173733
• MDR Text Key: 96696827
• Report Number: 1119421-2018-00030
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: AU00T0
• Device Lot Number: 12481726
• Other Device ID Number: 00380652381987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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): Other
• Patient Age: 81 YR