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

Model Number	TFNT00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaints reported in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during a cataract surgery with intraocular (iol) implant surgery, it was realized that the lens had a scratch in the entire half at the moment of fitting it in the eye.The doctor removed the lens with scissors and clamp and it come out shattered.Another lens with the same power was requested but there was no backup of this and it was reported for that they went to bring it.The patient was left in recovery with viscoelastic during the lens arrival.Once the lens arrived, the patient was taken back to the surgery rooms to implant the lens under viscoelastic and it was washed.The lens was implanted in the left eye, a paracentesis was sealed and antibiotics were left.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
The assembled lens case, the associate company cartridge, and the explanted lens were returned inside the opened carton.The lens was returned inside folded white gauze wrapped in taped plastic.Upon unwrapping, viscoelastic was observed dried on the lens.One haptic was broken in the gusset area.The other haptic was broken extended into the optic material.The broken haptics were returned.The optic was broken into two large portions.The optic has a long linear scratch with additional scratches.The optic also has cracked areas and split areas.The qualified company cartridge was returned.An insufficient amount of viscoelastic was observed.The cartridge tip was stressed.The cartridge has evidence of being placed into a handpiece.Information was provided that a qualified viscoelastic was used with the lens/cartridge combination.The reported scratch was observed.The root cause was most likely related to a failure to follow the instructions for use (ifu).An inadequate amount of viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovds) (diagram provided) 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 manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 13506972
• Report Number: 1119421-2022-00226
• Device Sequence Number: 5114917
• Product Code: MFK
• UDI-Device Identifier: 00380652357746
• UDI-Public: 00380652357746
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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 Expiration Date: 05/04/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.205
• Device Lot Number: 15192129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: DUOVISC; INFINITI HANDPIECE; MONARCH CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male