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

Model Number	DAT615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported following the intraocular lens implantation the patient had experienced corneal edema and a rise in the intraocular pressure.The patient had also complained about poor vision three days post operative.One week post operative the patient complained about vision not as sharp as hw would like it to be and states that there was no major improvement in the vision.Felt the vision was better out of the other eye with specs on than the surgery eye.There was no discomfort or irritation.The intraocular pressure was normal one week post surgery.Patient uncorrected distance vision is satisfactory and the patient was pleased with the visual outcome.The patient is also considering an lens exchange for the left eye as the lens was too strong.Addition information has been received stating the lens was explanted in a secondary procedure.
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.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Information was provided that the stigmatism and visual issues were related to a calculation error.The 17.5 diopter lens was replaced with a non-toric 18.5 diopter lens.The degree of difference in the cylinder and spherical powers would support a calculation error.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and reported that the iol was exchanged for the different diopter power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.This was a measurement error that was not caught before surgery.

• 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: 14485867
• Report Number: 1119421-2022-01105
• Device Sequence Number: 4735595
• Product Code: POE
• UDI-Device Identifier: 00380652426220
• UDI-Public: 00380652426220
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 06/19/2026
• Device Model Number: DAT615
• Device Lot Number: 15218478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF IQ VIVITY; ARGOS BIOMETER; ORA SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male