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

Model Number	TFNT00
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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 health care professional reported that before surgery, they have noticed that the lens were defects before they were implanted.So, the surgery was delayed by 2 minutes.No patient was affected.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was added in h.3., h.6.And h.11.The product was not returned.Photo(s) were provided.Only one photo is of a tablet screen showing an opened lens case (serial number not in the photo).The photo is blurry.The lens appears to be positioned incorrectly in the lens case.One haptic was observed to be bent with the distal area extending into drain hole of the lens case.The other haptic appears to be possibly broken in the gusset area.The clarity of the photo is too poor to make further confirmations of damage or handling.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used with the lens.The complaint was reported as "lens defect was noticed before they were implanted".The specific "lens defect" was not provided.Based on our observation of the attached photo, one haptic was bent.The other haptic may have also been damaged.The presence of clinical solution on the lens cannot be determined from the photo.It is difficult to make a determination of handling and damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.Information indicated that an additional lens was ordered and the surgery was completed.The file indicated that the patient was not affected.It is unknown if the "defect" was noticed when opened or if the reported lens issue occurred during loading.The instructions for use (ifu) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ophthalmic viscosurgical device (ovd)-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.It is unknown if qualified associated products were used.The ifu instructs: company foldable intraocular lenses (iols) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company 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.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information or the sample 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: 20531574
• Report Number: 1119421-2024-02081
• Device Sequence Number: 6641216
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: (01)00380652357791(17)271003(11)221005(10)15481523
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: TFNT00
• Device Catalogue Number: TFNT00.230
• Device Lot Number: 15481523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 10/05/2022
• 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
• Patient Sex: Unknown