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

Model Number	DAT015
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
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.Two other complaints for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision and myopia.Additional information was received that indicated prior to the iol exchange, a procedure was performed to reposition the iol with a suture.The surgeon stated the optics of the company (implanted) lens may not work with the patient's eye, therefore the iol was exchanged 29 days following the initial implant procedure.
Additional Manufacturer Narrative
The customer indicated, the use of a qualified company and company handpiece.The customer indicated, the use of a viscoelastic.Which is not qualified for company cartridge use.Information was provided, that the company lens 16.0 diopter, (1.5 extended depth of focus) lens was replaced with a non-company 15.0 diopter, monofocal lens model.Additional information was provided, that in the surgeon's opinion, the "optics of company lens may not work with the patient's eye".Due to the exchange of a multifocal lens to a monofocal lens, this may suggest, that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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 ; 8175514979
• MDR Report Key: 12582428
• Report Number: 1119421-2021-01892
• Device Sequence Number: 3289241
• Product Code: POE
• UDI-Device Identifier: 00380652424554
• UDI-Public: 00380652424554
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2021

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: 02/15/2025
• Device Model Number: DAT015
• Device Lot Number: 15032709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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: AMVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; AMVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female