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

Model Number	TFNT40
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during the intraocular lens (iol) implant procedure haptic was broken at the junction of optic.The lens was implanted.There were no patient harm.Additional information has been requested that the lens was explanted because the lens was decentered and misaligned from the astigmatic axis.The patient did not suffer any intraocular damage.
Additional Manufacturer Narrative
The product was not returned.Photos were provided.Two of the photos appeared to show the lens just after it was delivered.The axis alignment marks were visible on the eye in both photos (purple lines).The first photo appeared to be just after implant as one haptic has not unfolded.The lens was off-center to the left of the eye.One haptic was visible on the anterior optic surface.The second photo showed the lens in the eye.The haptic had unfolded.The lens had not been dialed in to the marked axis on the eye (purple ink).Both gusset areas were visible.The haptics were not visible.No abnormalities or damage could be observed due to the clarity of the photo.The last photo appeared to be before the explant.No purple axis alignment marks were visible.The lens appeared to be decentered in the eye.Off-axis could not be determined as measurements were not marked.What may have been a small chip was observed at the visible gusset area.No breaks were visible in the photo.The haptics were not visible.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and qualified handpiece with a non-qualified viscoelastic.The product was not able to be returned for evaluation.The reported broken haptic (lower third of the proximal haptic fragmented) could not be verified because the damage was not visible in the provided photos.The lens did appear to be off-center.The off-axis could not be determined as the measurements were not marked in the last photo.The root cause for the reported broken haptic may be related to a failure to follow the instructions (ifu).A non-qualified viscoelastic was indicated.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu 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: 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.Information was provided that the patient did not suffer any intraocular damage.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: 19151529
• Report Number: 1119421-2024-00766
• Device Sequence Number: 9383705
• Product Code: MFK
• UDI-Device Identifier: 00380652390576
• UDI-Public: 00380652390576
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: TFNT40
• Device Catalogue Number: TFNT40.225
• Device Lot Number: 15670716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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: METHYLCELLULOSE VISCOELASTIC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male