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

Model Number	TFNT30
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional reported that during surgery, doctor noticed that there is a crack on the edge of the optic and haptic.While implantation, ¾ of the iol was inserted when she noticed that there is a resistance to proceed.She retracted the monarch to stop inserting but the haptic was detached to the optic, it advanced and was fully inserted inside the eye.Doctor doesn't have iol (intraocular lens) cutter so she proceeds and finished the surgery and the optic was inserted to the eye so, they will explant the iol if the patient was ready for surgery again.Additional information has been requested.
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).
Additional Manufacturer Narrative
Corrected information provided in d.4.Additional information has been provided in h.3., h.6., and h.11 the assembled lens case and the cut lens carton were returned with the used company cartridge.The cartridge was wrapped in white gauze material.Inadequate viscoelastic was observed in the cartridge.The lens nor the broken haptic observed in the photo were returned in cartridge.The cartridge tip has stress lines.The cartridge wings have evidence of handpiece use.Photos were provided.The photo of the sample displayed a misfolded and broken trailing haptic in the company cartridge.The cartridge was secured into the handpiece in the photo.The handpiece plunger was retracted to the nozzle entry area of the cartridge.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge, handpiece, and viscoelastic were indicated.Based on evaluation of the photo, the trailing haptic was misfolded and broken inside the company cartridge.An evaluation of the reported crack on edge of optic cannot be conducted because the remainder of the lens is currently implanted.The root cause for the reported complaint may be related to a failure to follow the ifu.Based on evaluation of the returned cartridge sample, an inadequate amount of viscoelastic was observed in the returned cartridge.The iol (intraocular lens) ifu (instructions for use) instructs that an 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.The ifu instructs to completely fill the cartridge with ovd (viscosurgical device) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The 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 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.The position of the trailing haptic observed in the photo would indicate that the haptic was not in a correct position for advancement.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.Information was provided that the remainder of the lens may be explanted at a later date.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 TORIC 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: 20394407
• Report Number: 1119421-2024-01964
• Device Sequence Number: 8008613
• Product Code: MFK
• UDI-Device Identifier: 00380652390026
• UDI-Public: (01)00380652390026(17)280328(11)230331(10)15617422(21)15617422020
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/04/2024

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: TFNT30
• Device Catalogue Number: TFNT30.225
• Device Lot Number: 15617422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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 , CARTRIDGE D.; MONARCH III IOL , INJECTOR.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown