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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
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 have been no other complaints reported in the lot number.Additional information was requested, but no further information is available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that after implantation of an intraocular lens (iol) the lens was explanted (unknown reason).Additional information was requested.
Additional Manufacturer Narrative
Information was provided that the company lens of 18.0 diopter (1.5 extended depth of focus) lens was replaced with a monofocal 25.5 diopter lens.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information was added.The iol was replaced with a different iol due to blur eye post operation.As per the physician there is no abnormality and sees no obvious etiology for the outcome.

• 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
• MDR Report Key: 12121524
• Report Number: 1119421-2021-01324
• Device Sequence Number: 11704415
• Product Code: POE
• UDI-Device Identifier: 00380652424592
• UDI-Public: 00380652424592
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/06/2021

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: 03/22/2025
• Device Model Number: DAT015
• Device Lot Number: 15062591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE D; MONARCH III IOL INJECTOR; UNSPECIFIED VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR