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

Model Number AU00T0

Device Problem Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported experiencing resistance when trying to push the lens out of the injector during an intraocular lens (iol) implant procedure using a preloaded delivery system.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned loose and separate in biohazard bags.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.The posterior of the tip at the wound guard has an aneurysm that extends into a split through the tip end.Stress is also observed.The anterior surface of beveled tip is bent backwards (flattened) as if placed on its end on a hard surface.The lens was returned inside a small blue dish like container inside the bag.Solution was observed on the lens.The posterior optic surface has a small scrape mark near the edge.No other damage observed.The root cause for the complaint of ¿resistance with pushing lens through cartridge¿ cannot be determined.The device and lens were returned separately.The nozzle tip has an aneurysm and a has split on the bottom right.This damage would indicate the lens and/or plunger were not in a proper position for advancement.Excessive force would have been necessary to cause this type of atypical damage.The lens was also damaged.The directions for use (dfu) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Other damage was observed to the upper portion of the nozzle tip (bent back).This damage may have occurred due to the device being returned unsecured.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7371827
• MDR Text Key: 103660694
• Report Number: 1119421-2018-00328
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12557419
• Other Device ID Number: 00380652394703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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