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 Code	Visual Impairment (2138)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that, following an intraocular lens (iol) implant procedure, the patient was unhappy with distance visual acuity.The iol was replaced with another iol.The clinical reason for explant was given as residual mixture.Additional information requested.
Additional Manufacturer Narrative
The customer indicated, the use of a qualified company cartridge and viscoelastic.The customer indicated, the use of an unknown handpiece.It is unknown, if a qualified product was used.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.The 22.0 diopter, (1.5 extended depth of focus) lens was replaced with a 15.5 diopter (add power +2.2/+3.2) lens.The product was not returned to evaluate.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
• MDR Report Key: 12352004
• Report Number: 1119421-2021-01601
• Device Sequence Number: 11710941
• Product Code: POE
• UDI-Device Identifier: 00380652424677
• UDI-Public: 00380652424677
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/15/2021

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: 08/17/2025
• Device Model Number: DAT015
• Device Lot Number: 15092762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/22/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL CARTRIDGE D; UNSPECIFIED HANDPIECE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR