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	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, patient don¿t have a good sight, doctor spun the lenses but still vision was not good at distance, midrange and in reading.The visual acuity was bad all-around.Additional information has been received stated that consumer could not see red for a week, after implant.The doctor spun the lenses on (b)(6) 2022.No further information available.Additional information has been requested and received stated that consumer was dissatisfied from the lenses and did not experienced good vision from both the eyes.There are two medical device reports associated with this patient.This is 2 of 2 files.
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
Additional information provided in h.3., h.6.And h.10.The product was not returned.Product history records were reviewed and the 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 to evaluate.Follow up attempts were made to the doctors office.No further information has been provided.Patient indicated seeking another opinion.There have been no other complaints reported in the lot number.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: 14987352
• Report Number: 1119421-2022-01513
• Device Sequence Number: 13852195
• Product Code: POE
• UDI-Device Identifier: 00380652427784
• UDI-Public: 00380652427784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 06/22/2026
• Device Model Number: DAT415
• Device Lot Number: 15221312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male