MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT615
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An administrator reported that following an intraocular lens (iol) implant procedure, the patient had expected vision not obtained, dislocated iol.The iol was exchanged in a secondary procedure following the initial procedure.Additional information has been requested and provided that there was no patient harm and no hospitalization.
Additional 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 number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece.The viscoelastic indicated is not qualified for the lens/cartridge used.The product investigation could not identify a root cause for the reported complaint.Information was provided that the (3.75cyl), 17.0 diopter, (1.5 extended depth of focus) lens was replaced with a monofocal 17.0 diopter lens with a reason for the exchange of "lens dislocated temporarily." no additional information has been provided at this time at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14641693
• Report Number: 1119421-2022-01219
• Device Sequence Number: 4919651
• Product Code: POE
• UDI-Device Identifier: 00380652426213
• UDI-Public: 00380652426213
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: DAT615
• Device Lot Number: 15193871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF MULTIPIECE IOL; AMVISC; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male