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

Model Number AU00T0

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract surgery with an intraocular lens (iol) implantation, they had difficulty implanting the iol during insertion after setup was done.The iol was clogged during insertion.The surgery was completed after replacing the product with another one.Additional information has been requested.

Manufacturer Narrative

Additional information was provided on d.10., h.3., h.6.And h.10.Evaluation summary: the device with the lens was returned loose in the carton.The plunger lock and lens stop have been removed.The plunger was oriented incorrectly.Viscoelastic was observed in the device.The plunger was advanced over the lens to the middle of the lens loading area.The lens was located in the lens loading area with leading haptic and leading optic edge extended into the nozzle entry area.Product history and records were reviewed and documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported event.The used device was inspected.A plunger override was observed.The majority of the lens is still within the loading area.Upon return, the plunger was observed to be oriented incorrectly in the device.It cannot be determined if the plunger may have been inadvertently retracted outside of the device and reinserted incorrectly by the customer.Although the plunger orientation cannot be ruled out as a potential cause, it is unlikely that the device was manufactured incorrectly.Plunger placement is conducted with a plunger/main body assembly fixture.The fixture by design ensures the proper orientation and placement of the plunger in the device.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, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10627165
• MDR Text Key: 210616781
• Report Number: 1119421-2020-01374
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12640236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON