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

Model Number	TFNT00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.An attached photo shows the lens outside the lens case in what appears to be a specimen cup on a piece of surgical sponge.Solution appears to be on the lens.Both haptics are broken in the gusset area.One broken haptic is shown laying beside the lens.The other haptic appears to be adhered by solution to the anterior optic surface.We cannot make a determination of root cause from the photo.Complaint and product history records were reviewed and documentation indicated the product met release criteria.A qualified lens/cartridge combination was indicated.The file indicated the use of a non-qualified viscoelastic.The root cause for the reported complaint appears to be related to failure to follow the instructions for use (ifu).The file indicated the use of a viscoelastic that is not qualified for the product combination used.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.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during a implant surgery, one haptic of the lens broken inside the eye.On removal the other haptic broke too.Additional information received and confirmed that, the procedure completed with an enlarged incision plus suture and removed broken intraocular lens and replaced with back up iol.
Additional Manufacturer Narrative
The lens was returned in a specimen container adhered to a piece of paper.Solution was dried on the lens.Both haptics were broken (returned).One haptic was broken from the gusset area.The other haptic was broken from the haptic/optic junction area.The attached photo appears to be of the returned sample.The reported broken haptic was observed.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
There was no patient harm reported.

• 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: 14588828
• Report Number: 1119421-2022-01187
• Device Sequence Number: 2095831
• Product Code: MFK
• UDI-Device Identifier: 00380652357883
• UDI-Public: 00380652357883
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.275
• Device Lot Number: 12762043
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2019
• 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 II, CARTRIDGE B.; VISTHESIA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female