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

Model Number	DFT315
Medical Device Problem Codes	Difficult to Advance (2920); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that after implantation of an intraocular lens (iol) the lens was unusually stuck in a folded condition for a longer period after it started to unfold there was a stretch mark in the middle.The surgery was completed but reserving the chance of explantation and re-implant with new lens.Additional information was requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.The product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified the manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3, h.6 and h.10.The provided photo shows a video screen displaying an image of the lens in the eye.What appears to be a linear mark is observed near the center of the optic.We are unable to make a determination from the photo.The account indicated the use of a qualified cartridge and viscoelastic.The associated handpiece was not provided.It is unknown if a qualified handpiece was used.Based on our observation of the attached photo, the lens appears to have a linear mark/scratch.The product was not returned to evaluate.It is difficult to make a final determination without evaluation of the physical sample.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC 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: 15103096
• Report Number: 1119421-2022-01625
• Device Sequence Number: 5187706
• Product Code: POE
• UDI-Device Identifier: 00380652421522
• UDI-Public: 00380652421522
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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 Model Number: DFT315
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DUOVISC; MONARCH III IOL CARTRIDGE C
• Patient Sex: Female