MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SA6AT3

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blurred Vision (2137)

Event Type  Injury  

Event Description

A facility representative reported that following an intraocular lens (iol) implant procedure, patient experienced blurry vision.The iol was explanted and exchanged for an unknown atiol following the initial implant procedure.Additional information has been requested.

Manufacturer Narrative

A sample device 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.The manufacturer internal reference number is: (b)(4).

Event Description

Clinical reason being decentered iol.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company toric lens was replaced with a non-toric company lens.The exchange of a toric lens to a non-toric lens with a 1.0 diopter change in the spherical power, may suggest that the replacement lens model was an improved choice for the patient's vision needs.File will be reopened if the product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17405866
• MDR Text Key: 319865785
• Report Number: 1119421-2023-01337
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652335850
• UDI-Public: 00380652335850
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA6AT3
• Device Lot Number: 15103778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REPLACEMENT LENS- REPLACED WITH UNKNOWN ATIOL
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR