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	10/14/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, reported with a description of when the iol was already in the capsular bag, the surgeon, while adjusting the haptic elements, discovered that one of the haptics had a tear in the area where it attaches to the optical part.The decision was made to leave the lens with one intact haptic in the patient's capsular bag.Next day the surgeon re-implanted the iol, replaced it with unspecified lens.There was no patient harm.Additional information has been received includes patient details.
Additional Manufacturer Narrative
A photo was available in the file.The lens case was shown opened with the lid facing up, mylar visible and legible.The base of the lens case displayed one broken haptic outside the well area of the lens case.There is a slight reflection on the haptic.It cannot be determined if the reflection is indicative of viscoelastic placed on lens.The remainder of the lens was not present in the photo.The photo was magnified for a better view.The broken haptic included from distal haptic tip down into the haptic/optic junction.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.Based on our observation of the attached photo, the haptic is broken.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).The viscoelastic indicated is not qualified for the lens/company combination used.The ifu instructs that an alcon qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.It is difficult to make a determination of handling / damage without evaluation of the physical sample.File will be reopened when new information or the product is received.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: 18109194
• Report Number: 1119421-2023-01882
• Device Sequence Number: 6004430
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: 00380652357791
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 01/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.230
• Device Lot Number: 15470972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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: APPAVISC PFS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female