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

Model Number	DAT015
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional 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.There has been two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A patient reported that, following intraocular lens (iol) implant procedure, the lens was dislocated in eye.Patient had a revision.As well as a yag (yttrium aluminum garnet) procedure.He became nearsighted completely.He is a detriment driving, but if he doesn't drive, he will be unemployed! additional information was received that patient's understanding is due to the shape/lack of depth to his eye the doctor had to reposition the iol in another surgery.There are two medical device reports associated with this patient.This report is for left eye.
Additional 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.There has been two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A patient reported that, following intraocular lens (iol) implant procedure, the lens was dislocated in eye.Patient had a revision.As well as a yag (yttrium aluminum garnet) procedure.He became nearsighted completely.He is a detriment driving, but if he doesn't drive, he will be unemployed! additional information was received that patient's understanding is due to the shape/lack of depth to his eye the doctor had to reposition the iol in another surgery.There are two medical device reports associated with this patient.This report is for left eye.
Additional Manufacturer Narrative
Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received that the patient was very upset that results did not find anything.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that, the lens was not dislocated in eye, the optic shifted forward peeking through the capsularhexis incision for unknown reasons.The surgeon then reopened the rhexsis incision and freed up the lens, which is now well centered and then did a yag later on.Lens looks beautiful now, great centering and positioning.The patient had myopic lasik, dry eye syndrome, punctal plugs and on artificial tears.No clinical reason for poor vision.
Additional Manufacturer Narrative
Additional information was provided in b.5 and h.3.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that, lenses are defective.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that patient cannot continue with this quality of vision/life anymore.She has been dealing with it as patiently as possible.

• 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 ; 8007579780
• MDR Report Key: 13472390
• Report Number: 1119421-2022-00199
• Device Sequence Number: 20006320
• Product Code: POE
• UDI-Device Identifier: 00380652424653
• UDI-Public: 00380652424653
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/20/2022

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: 09/07/2025
• Device Model Number: DAT015
• Device Lot Number: 15095943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 04/14/2022; 05/16/2022; 05/26/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 04/01/2022; 05/10/2022; 05/25/2022; 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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: ARTIFICIAL TEARS; HEALON; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; MONARCH IOL CARTRIDGE; PUNCTAL PLUGS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male