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

Model Number	DAT315
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
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 requested and received.There are two medical device reports associated with this patient.This report is for right 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 have been no other complaints reported in the lot number.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).
Additional Manufacturer Narrative
The outcome of malfunction and fda product problem code ¿2923¿ was removed based on the follow up information, as there is no device malfunction (device dislocated) event involved presently.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that, the patient had lasik treatment and the lens was not dislocated.The patient was fully aware of risks with outcome being a refractive patient.No epiretinal membrane (erm) , no posterior vitreous detachment (pvd) and no corneal irregularities.Vision is poor both distance and near according to surgeon.
Event or Problem Description
Additional information was received that, lenses are defective.
Additional Manufacturer Narrative
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: 13493796
• Report Number: 1119421-2022-00214
• Device Sequence Number: 4705620
• Product Code: POE
• UDI-Device Identifier: 00380652427104
• UDI-Public: 00380652427104
• 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
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2026
• Device Model Number: DAT315
• Device Lot Number: 15213734
• 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; 04/13/2022; 05/26/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/01/2022; 05/10/2022; 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: ARTIFICIAL TEARS; HEALON; MONARCH III IOL INJECTOR; MONARCH IOL CARTRIDGE; PUNCTAL PLUGS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male