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

Model Number AU00T0

Device Problems Contamination (1120); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that an intraocular lens (iol) was inserted and removed due to a foreign body noted in the iol once it was inserted in the patient's eye.There was no reported patient harm.Additional information was requested.

Manufacturer Narrative

Only the lens was returned, transported inside a lens case in the opened carton.Viscoelastic and reddish colored solution (possibly blood) was observed on the explanted lens.The optic was cut into two pieces, typical in appearance to damage during removal from the eye.The optic portions are adhered in dried solution, one atop the other.One distal haptic tip has areas on the edge that are chipped.The anterior optic surface has an area that is cracked.The center of the optic has cracks that splintered into the material from the cut optic damage.The lens was removed from the lens case to further inspect.There was no foreign material observed other than clinical solution and what appears to be blood.The lens was cleaned separate the optic portions and to remove the solutions to better inspect for the reported "foreign bodies in the iol".Upon cleaning the lens and re-inspecting, there are no foreign bodies observed inside the iol.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported issue.The explanted lens was transported in a multipiece lens case.The lens had damage, viscoelastic, and what appears to be possibly blood.The optic was cut into two pieces, typical in appearance to lens damage during removal from the eye.There was no foreign material observed on the explanted lens surface except for the viscoelastic reddish solution (possibly blood, which would be expected following explant).The lens surfaces were cleaned to inspect for the reported "foreign bodies in the iol".There were no foreign materials observed inside the lens material.The reported complaint was not observed.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: 9789548
• MDR Text Key: 185152902
• Report Number: 1119421-2020-00386
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: AU00T0
• Device Lot Number: 12726626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC OVD