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

Model Number	TFNT40
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the distal tip area.One haptic is split near the gusset area.The lens is cut in half, typical of insertion and removal from the eye.Both halves are adhered to each other by solution.The lens was cleaned for further evaluation.Scratches and scrape marks are observed on the optic.Marks are observed on both sides of the optic that are similar to those left by a surgical instrument used to grasp the lens.Product history records were reviewed, and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The reported lens damage was observed.The root cause for the reported complaint may be related to a failure to follow the instruction for use (ifu).The viscoelastic indicated is not qualified for the lens/monarch combination used.Company foldable iols are qualified for use with a 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.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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery with intraocular lens (iol) implant procedure, a scratch in the optics was observed.The lens was removed during initial procedure and completed with another lens.Additional information received stating that patient had posterior capsule rupture and patient outcome was recovered.

• 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: 20005752
• Report Number: 1119421-2024-01602
• Device Sequence Number: 4376191
• Product Code: MFK
• UDI-Device Identifier: 00380652390583
• UDI-Public: (01)00380652390583(17)261207(11)211209(10)15316506
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.230
• Device Lot Number: 15316506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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: BIOVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male