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

Model Number	TFAT00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the iol was deployed with cracks around the edges.The cracked iol needed to be cut out of a patient and replace with a another iol to complete the procedure during initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot number.Two lenses were reported used with the same cartridge.Photos were provided.It is unknown which lens is the pictured lens.Photo #1: this photo shows a multifocal lens in the eye.One haptic gusset area is visible.Large, cracked areas are observed on the top and bottom of the optic edge.The damage is in the same location on each side.This may indicate a plunger override occurred, photos #2-4: these photos show the pak invoice and the lens cartons with the serial numbers.Photos #5: this photo shows a company cartridge in a specimen cup.No details can be observed.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and updated.
Additional Manufacturer Narrative
A photo was provided.This photo shows a multifocal lens in the eye.One haptic gusset area is visible.Large, cracked areas are observed on the top and bottom of the optic edge, midway between the haptic/optic junction areas.The damage is in the same location on each side.This may indicate a plunger override occurred.A cartridge was indicated.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.Information stated the cartridge was reused for this lens.Company cartridges are single use devices.The ifu (instructions for use) states: do not reuse the cartridge.The cartridge is for single use only.Reuse of this single-use device may result in serious injury.Review of the returned used company cartridge was inconclusive.Viscoelastic usage could not be determined because the cartridge was returned in liquid.No problem was found with the returned used company cartridge.Top coat dye stain testing was conducted with acceptable results.Per the ifu: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu also instructs to completely fill the cartridge with ovd 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.In addition, the ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING 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: 16156043
• Report Number: 1119421-2023-00085
• Device Sequence Number: 6958764
• Product Code: MFK
• UDI-Device Identifier: 00380652429788
• UDI-Public: 00380652429788
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: TFAT00
• Device Catalogue Number: TFAT00.235
• Device Lot Number: 15368705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/14/2023
• Date Device Manufactured: 03/18/2022
• 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 CARTRIDGE D
• Patient Age: 71 YR
• Patient Sex: Female