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

Model Number	TFNT00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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.The product was not returned.One photo shows the lens on a video monitor.One haptic was broken in the gusset area.The second photo of the lens shows the lens on the outer lip of the lens case base.One haptic was broken in the gusset area.We are unable to determine if solution was present on the lens due to the quality of the photos.Due to the lens being outside of the lens case shows that handling has occurred.Based on our observation of the attached photos, the haptic was broken.The presence of clinical solution on the lens cannot be confirmed.It is difficult to make a determination of handling / damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported during an intraocular lens (iol) implant procedure, haptic was broken when opened the lens package.The patient was left aphakic and second surgical action was required to insert the lens with no patient harm.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned in the lens case inside the opened carton.Solution was dried on the lens.A dark solution is observed on the edge of one of the haptics.One haptic is broken in the distal area with the broken piece adhered to the optic by solution.The opposite haptic is broken in the gusset area (not returned).A crack is observed in the center of the optic on the anterior side.A mark is observed near the crack.The returned lens matches the provided photo(s).The product investigation could not identify a root cause for the reported complaint.The reported haptic damage was observed.The observed lens damage is similar in appearance to handling related damage.The presence of the solution on the returned sample is evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present when opened.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 16485406
• Report Number: 1119421-2023-00389
• Device Sequence Number: 14867768
• Product Code: MFK
• UDI-Device Identifier: 00380652357937
• UDI-Public: 00380652357937
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 05/15/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.300
• Device Lot Number: 15200913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female