MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria.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 facility representative reported that following an intraocular lens (iol) implant procedure the patient reported blurry vision and difficulty with close up work.The iol was exchanged for clinical reason of lens rotated in a secondary procedure.Additional information was requested and received.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.10.The lens was returned for evaluation.Solution is dried on the lens.The lens was cut in half, typical of insertion and removal from the eye.Scratch marks are observed on both pieces of the optic.A piece of optic is missing on the edge where it was cut in half.The file indicates the use of a qualified cartridge and unspecified handpiece.A viscoelastic is provided that is approved with a qualified combination.The root cause for the reported events could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11840385
• Report Number: 1119421-2021-01044
• Device Sequence Number: 19959196
• Product Code: MFK
• UDI-Device Identifier: 00380652419147
• UDI-Public: 00380652419147
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.155
• Device Lot Number: 12722864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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: ACRYSOF TORIC IOL; DUOVISC; MONARCH III IOL CARTRIDGE D; UNSPECIFIED HANDPIECE; ACRYSOF TORIC IOL; DUOVISC; MONARCH III IOL CARTRIDGE D; UNSPECIFIED HANDPIECE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR