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

Model Number AU00T0

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.A root cause has not been identified.(b)(4).

Event Description

A physician reported that during a cataract removal with intraocular lens (iol) implant procedure, a problem was presented in the way the pre-loaded injector delivered the lens, showing the lens deformed.There was no impact for the patient, and the surgery was completed with another iol and injector system.

Manufacturer Narrative

Additional information provided.Product evaluation: the device and the lens were returned.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has been retracted to mid-nozzle.No damage was observed.The lens was returned adhered to the outside of the device with viscoelastic.The lens was cleaned with lphse to remove it from the device.The lens dimensions were acceptable (plan view) using an approved template.No lens damage was observed.A qualified viscoelastic was indicated.The root cause could not be determined.The lens was returned outside of the device.The lens dimensions are acceptable (plan view) using an approved template.No lens or device damage was observed.The manufacturer internal reference number is: (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: 7316679
• MDR Text Key: 101845233
• Report Number: 1119421-2018-00238
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12547008
• Other Device ID Number: 00380652358286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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): Other