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

Model Number	DAT415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 implantation of an intraocular lens (iol) the patient experienced vision difficulty and cotton wool spots (retina problem).The lens was explanted.New information received reporting the patient was sent to explant.Post operation of 7 days patient experienced vision difficulties and cotton wool spots (retinal problem).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified company cartridge and handpiece.The customer indicated the use of a viscoelastic, which is not qualified for the lens/company cartridge/handpiece combination used.Information was provided that in the surgeon's opinion the lens did not cause or contribute to the event.The patient saw a retina specialist and was found to have cw spots ou.Cw spots believed to be caused by covid.Patient had prior lasik surgery.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
• MDR Report Key: 11921696
• Report Number: 1119421-2021-01148
• Device Sequence Number: 11580444
• Product Code: POE
• UDI-Device Identifier: 00380652427968
• UDI-Public: 380652427968
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 03/08/2025
• Device Model Number: DAT415
• Device Lot Number: 15057650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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 DELIVERY SYSTEM; OVD:AMVISC; MONARCH III CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM; OVD:AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR