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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced significant biometric deviation in the post-operative period due to the fact that she had undergone previous laser surgery in another service, using the high-grade lasik technique.Due to the high curvature of the cornea, which makes it impossible to apply a new laser to treat the residual degree it was decided to change the intraocular lens.The lens was exchanged for another lens model 22 days following the initial procedure.
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).
Additional Manufacturer Narrative
Additional information was provided in e.1.,h.3.,h.6 and h.11.The lens has not returned for an evaluation.A photo was available in the file.An ungloved hand was shown holding a small specimen jar with what appeared to be a taped patient information label for surgery.The jar was filled with clear liquid.A yellow lens model was observed at the bottom of the fluid filled jar.The optic appeared to be cut into pieces, typical of a removal from the eye.There appeared to be at least one broken haptic.Further confirmation cannot be made without the physical sample.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and handpiece were used.A non-qualified viscoelastic was indicated.Based on information provided by the reporter, the root cause may be related to the patient and unrelated to the product.The reporter indicated that the patient had a significant biometric deviation in the post-operative period due to the fact of undergoing previous laser surgery in another service, using the high-grade lasik technique.Due to the high curvature of the cornea, which makes it impossible to apply a new laser to treat the residual degree, it was decided to change the intraocular lens.Based on the provided photo, the lens was cut into pieces and was placed into a small jar filled with clear liquid.The sample has not returned for an evaluation.Each lens is subjected to a 100 percent assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The file indicated that the lens was exchanged.The replacement lens model and diopter was not provided.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: 19826575
• Report Number: 1119421-2024-01400
• Device Sequence Number: 8695526
• Product Code: MFK
• UDI-Device Identifier: 00380652390521
• UDI-Public: (01)00380652390521(17)280728(11)230731(10)15693917(21)15693917088
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.200
• Device Lot Number: 15693917
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/02/2024
• Date Device Manufactured: 07/31/2023
• 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: HEALON (DISPERSIVO).LOT: 030209.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; UNSPECIFIED REPLACEMENT LENS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female