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

Model Number	DFT015
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: complaint history records were reviewed.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported upon implanting an intraocular lens (iol), there was a grey deposit in the center of the implanted lens.There was no reported patient harm.During a follow up check, the surgeon did not see the deposit in the lens any longer.Additional information was requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic is observed on the lens.One haptic is broken-gusset area not returned.The remaining haptic is broken-distal area, broken portion in lens case.The optic has been cut into two pieces returned adhered to each other.The lens was cleaned with lphse for further evaluation.The two pieces were separated.One optic portion has a gouge/divot with material removed on the anterior surface.There are small v-shaped cracks at the start of the damaged area.This damage matches the area observed in the provided photo.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated.The lens was returned and damage was observed.The damage was not observed until after the lens was implanted.It cannot be verified that the product was damaged before use.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met alcon¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.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).

• 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: 11423013
• Report Number: 1119421-2021-00490
• Device Sequence Number: 11914934
• Product Code: POE
• UDI-Device Identifier: 00380652421218
• UDI-Public: 00380652421218
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2025
• Device Model Number: DFT015
• Device Lot Number: 15060141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/03/2021; 03/26/2021; 04/22/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 03/17/2021; 03/31/2021; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III D CARTRIDGES; MONARCH III IOL DELIVERY SYST; OVD: BIOLON