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

Model Number SA6AT3

Device Problem Malposition of Device (2616)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Type  Injury  

Event Description

A non health care professional reported that following the intraocular lens (iol) implant procedure, the patient experienced poor near vision.The iol was exchanged in a secondary procedure.The clinical reason for explant was iol rotation resulting in induced astigmatism, under corrected myopia.There was no patient harm.The physician prognosis was good.

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot.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: 15244946
• MDR Text Key: 298111434
• Report Number: 1119421-2022-01791
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652335751
• UDI-Public: 00380652335751
• 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
• Report Date: 08/17/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: SA6AT3
• Device Lot Number: 15105003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF TORIC SINGLEPIECE IOL; MONARCH CARTRIDGE D; MONARCH INJECTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male