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

Model Number AU00T0

Device Problems Failure to Deliver (2338); Defective Device (2588)

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

Event Date 06/07/2021

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 an intraocular lens (iol) implantation procedure, at the time of placing viscoelastic on the lens, the scrub nurse realizes that the cavity where the lens is located was a little open and closes it, places the viscoelastic forward in the lens in the mouthpiece and hands it over to the doctor.At the time of implanting the lens in the eye, the doctor has difficulty for the lens to advance and pushing with the plunger the lens becomes stuck.They wanted to remove the lens to load it into another cartridge but the lens was disfigured, it was decided not to implant.

Manufacturer Narrative

Evaluation summary: the product was not returned.Three photos were provided.The first photo shows the device from the bottom.The serial number is visible and matches the reported product.The lens can be observed in the loading area.The plunger is slightly advanced into the loading area, not touching the lens (may have been retracted).The trailing haptic does not appear to be folded.There appears to be viscoelastic in and on the device.The second photo is from the side of the optic.No damage can be seen.The third photo shows the lens from the posterior side, there appear to be linear marks across the optic surface from side to side.Marks are also observed on the optic edge.Product history records were reviewed and 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 report complaint could not be determined.The lens appeared to be damaged in the provided photo.Based on the information provided a plunger over/underride may have occurred due to a misplaced lens.It was stated that the device door was found to be open when adding the viscoelastic.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: 12042862
• MDR Text Key: 257497585
• Report Number: 1119421-2021-01249
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394772
• UDI-Public: 00380652394772
• 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: 08/17/2021

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: Health Professional
• Device Expiration Date: 02/12/2023
• Device Model Number: AU00T0
• Device Lot Number: 15031698
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1