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

Model Number	DFT015
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
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.There were no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A doctor reported that following implantation of an intraocular lens (iol) patient experienced double vision.The lens was explanted in the secondary procedure.Additional information was received reporting in the surgeon's opinion, monocular double images shifted upwards on with the left eye caused or contributed to the event.
Additional Manufacturer Narrative
Correction data provided in h.6.The lens was returned for evaluation.Solution is dried on the lens.Identical marks are seen on the posterior and anterior sides of the optic in the shape of an surgical instrument used to grasp the lens observed.Light scratches are observed on the optic.Deep scratch marks are observed on the posterior surface of the optic.All product and batch history records are quality reviewed prior to product release.A verification of the power and resolution of the lens was performed with acceptable results.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported issue.No anomalies were observed in the material of the lens other than damaged caused by handling of the lens.The director of customer and technical affairs reviewed the attached wavefront photo and was unable to determine the cause of the complaint.Lens damage was observed.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating the iol was centered in the eye.
Additional Manufacturer Narrative
Additional photos were provided.The director of customer and technical affairs reviewed the photos and no determination of a defective lens could be made.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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
• MDR Report Key: 12007918
• Report Number: 1119421-2021-01222
• Device Sequence Number: 4328942
• Product Code: POE
• UDI-Device Identifier: 00380652421201
• UDI-Public: 00380652421201
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/30/2021

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: 09/30/2024
• Device Model Number: DFT015
• Device Lot Number: 12754941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 07/30/2021; 08/30/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/28/2021; 08/11/2021; 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention