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

Model Number AU00T0

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, a string of blue plastic pieces came through the incision and was floating in the eye.The foreign material was removed and the lens remains implanted.

Manufacturer Narrative

Only the device was returned loose in a bag.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic was observed inside the device.The plunger has been retracted into the nozzle entry area.No damage is observed.The plunger was removed to assess further.Viscoelastic is dried on the plunger.A small, slender blue colored fiber was observed loosely attached in viscoelastic located at the end of the plunger tip on the bottom.It is unknown if this observed fiber was the foreign material that was reportedly removed from the eye.A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the complaint of blue plastic pieces that came through the incision and were floating in the eye.A photo was not provided in order to determine the reported presence of foreign material floating in the eye.Updated information clarified that the lens remained implanted and the foreign material was removed.The reported blue plastic pieces were not observed.A small, slender blue colored fiber was returned loosely attached in viscoelastic located at the posterior end of the device plunger tip.This fiber may have been interpreted as the reported complaint of "blue plastic pieces".The fiber was sent to lab for testing.The fiber¿s best match was identified as cotton.Cotton is a common contaminant found in many environments, including manufacturing and surgical suites.The origin of the fiber cannot be determined 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: 9166648
• MDR Text Key: 172434294
• Report Number: 1119421-2019-01647
• 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: other
• Type of Report: Initial,Followup
• Report Date: 12/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12707347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC OVD
• Patient Age: 61 YR