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

Model Number	TFAT50
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned wrapped in surgical sponge.Solution is dried on the lens.Both haptics are bent in the gusset and distal area.The optic is cut into two portions, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were provided.The root cause for the reported event could not be determined.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The file indicates that the (3.00cyl), 6.5 diopter, add power +2.2 & 3.2 lens was replaced with a (3.75cyl), 6.0 diopter, add power +2.2 & 3.2 lens.Information was provided that in the surgeon's opinion, the lens did not cause or contribute to the event.In the surgeon's opinion "post operative iol rotation and under corrected astigmatism" was the cause of the event.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 had post operative iol rotation and under corrected astigmatism.The iol was exchanged for another lens (same model), 61 days following the initial procedure due to residual/under corrected astigmatism.Additional information was requested and received.

• 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: 12438772
• Report Number: 1119421-2021-01710
• Device Sequence Number: 4891649
• Product Code: MFK
• UDI-Device Identifier: 00380652419499
• UDI-Public: 00380652419499
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/08/2021

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: 08/31/2024
• Device Model Number: TFAT50
• Device Catalogue Number: TFAT50.065
• Device Lot Number: 12740825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/08/2021
• 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 CARTRIDGE D; MONARCH III INJECTOR; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR