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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Visual Impairment (2138); Visual Disturbances (2140); Dry Mouth (4485); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported following the intraocular lens implantation the patient had complications a week after the first week, and was diagnosed as an infection in the eye.The symptoms that the patient had experienced was constant dry eye and seeing rings on light at night.The patient was unable to see anything unless in very bright lights all the time.The letters continue to be more fuzzy and hardly had a time where the letters were clear and crisp regardless of the distance of the words.The patient was constantly having vision changes every 6 months.The physician thinks that the vision was good and was 20/20 but the letters were not crisp.The patient was diagnosed with guttata based on the cell count of eyes.Nine months post-op yag was performed.Which helped only for a short time.The reporter added the rings at night and inability to read in medium to darker lighting are the most difficult parts about all of this.There are two medical device reports associated with this patient.This report is for the right eye.
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.Information was provided that this was a clear lens exchange, not a cataract surgery.Both eyes were done on (b)(6) 2022.Patient indicated last visit with health care professional (hcp) they requested to explant the lenses (9 months post operation).Hcp indicated to patient that would not be beneficial.Hcp stressed there was nothing wrong with the product.Yttrium aluminum garnet (yag) laser treatment was done at this visit, which helped a bit, and only for a short time.Patient brochure was provided.Consumer was encouraged to contact the hcp or obtain a second opinion about concerns.Consumer did not consent to company contact with the hcp.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: 16458492
• Report Number: 1119421-2023-00373
• Device Sequence Number: 6449432
• Product Code: POE
• UDI-Device Identifier: 00380652427098
• UDI-Public: 00380652427098
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: 09/08/2025
• Device Model Number: DAT315
• Device Lot Number: 15095841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown