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

Model Number	DFT015
Medical Device Problem Codes	Application Program Problem: Power Calculation Error (1473); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported missrefraction after lens implantation bilateral.Explantation and exchange required.The patient was seen for pre-examination in 2021 after prk.We had also performed the calculation after hyperoperative ascrs.The first implantations were od on (b)(6) 2023.The overrefractions in both eyes were on (b)(6) 2023: od -1.25 cyl -0.25 a 20°; vcc=1.0; vsc=0.25.Os -1.00 cyl -0.25 a 50°; vcc=0.8; vsc=0.4.Explantation and reimplantation were os on (b)(6) 2023.The objective refraction (autorefractometer) was on (b)(6) 2023.Od +0.25 cyl -0.25; vsc=0.8 (2d post-op).Os +0.25 cyl -1.00; vsc=0.8 (1d post-op).Additional information has been requested.There are two files associated with this event in the patient.This file belongs to 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).
Event or Problem Description
Additional information has been requested and received stating that lens was exchanged for a 1.5 diopter more of same model company lens.The iols that were explanted during the exchange were discarded and therefore no longer available.The underlying cause is ¿ideopathic¿.The calculations of the originally implanted iol were carried out using ascrs post-hyperopic-prk and anterion post-lasik calculation.Taking into account all eventualities.Patient was now very satisfied.There were no adverse effects on the patient and no unscheduled treatment or medication was necessary.No hospital stay.As described status after (hyperopic) prk many years ago, which was not carried out by us.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury/malfunction.No further reports required.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION 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: 18383863
• Report Number: 1119421-2023-02200
• Device Sequence Number: 3967778
• Product Code: POE
• UDI-Device Identifier: 00380652421324
• UDI-Public: 00380652421324
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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 Model Number: DFT015
• Device Lot Number: 15589538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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: 60 YR
• Patient Sex: Female