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

Model Number	TFNT00
Medical Device Problem Codes	Defective Device (2588); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
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 pharmacist reported via regulatory authority stating during intraocular lens (iol) implant procedure, the surgeon noticed after implanting intraocular lens (iol), an apparent irregularity in the optics of the iol in the central area, a possible manufacturing defect or superficial abrasion of the iol.The lens was removed during initial procedure.The procedure was completed on same day.Additional information has been received stating no patient harm.
Additional Manufacturer Narrative
The product was not returned.A photo was provided.The lens carton displaying the product information was held in an ungloved hand along with a small clear specimen jar.A yellow lens model was observed submerged in clear liquid inside the jar.No determination can be made from this photo regarding the optical area.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified cartridge, handpiece, and viscoelastic combination was used.The product investigation could not identify a root cause for the reported complaint.Based on the photo provided, a yellow lens model was observed submerged in clear liquid inside the jar.No determination can be made from this photo regarding the optical area.The product was not returned.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.The instruction 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.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: 20154715
• Report Number: 1119421-2024-01745
• Device Sequence Number: 4247650
• Product Code: MFK
• UDI-Device Identifier: 00380652357852
• UDI-Public: (01)00380652357852(17)280604(11)230607(10)15652291(21)15652291068
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2024

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: TFNT00.260
• Device Lot Number: 15652291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/05/2024
• Date Device Manufactured: 06/07/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; UNSPECIFIED REPLACEMENT LENS; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 59 YR
• Patient Sex: Female