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 Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.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 during an intraocular lens (iol) implant procedure using a preloaded delivery system, the lens was stuck.The plunger was pushed but 'nothing happened'.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned.The plunger lock and lens stop have been removed.Viscoelastic is observed in the device.The plunger has been removed and returned separate from the device barrel.The lens was present in the lens loading area.It cannot be verified if the lens was advanced beyond the loading area or if the lens was placed in the lens loading area for return shipment.The device tip has extreme bent damage upon return.The separated plunger shows evidence of being advanced within a device.No damage was observed to the plunger.The plunger was reinserted inside the barrel for evaluation.No plunger anomalies were observed.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The root cause for the complaint of "failure to load/pushed plunger, patient contact" cannot be determined.The lens was in the device loading area and the plunger was returned removed from the device.Because the file indicated the device came into contact with the patient, the lens may have been placed back into the loading area for return shipment.The root cause of the event may be related to a failure to follow the directions for use (dfu).The 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, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.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.The plunger was returned separated from the device barrel.It is unknown if the plunger was inadvertently retracted.Per the dfu, do not attempt to retract the plunger after the plunger lock has been removed or plunger damage may result.Retracting the plunger can pull the tabs outside of the barrel and cause the plunger to release from the device.The extreme device tip damage may have occurred due to being returned loose.Procedures and processes exist within the manufacturing environment that focus on protection of the nozzle tip, including packaging of the device in a protective blister tray.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: 7558821
• MDR Text Key: 109755366
• Report Number: 1119421-2018-00688
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12565774
• Other Device ID Number: 00380652394741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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