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

Model Number	TFNT00
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, a haptic was seen to be warped upon opening the lens.The physician thought the lens could be used as the optic was fine.Upon inserting the iol, the haptic caused an immediate posterior capsule rupture.The iol had to be removed and replaced with a three piece lens.A vitrectomy was performed.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.10.Product evaluation: only half of the lens was returned for evaluation in the lens case.Solution was dried on the lens.The lens was cut in half, typical of insertion and removal.A dimensional inspection could not be conducted due to the extensive lens damage.The returned portion of the explanted lens had a haptic that was bent in the gusset and distal area.The other half of the lens was not returned for evaluation.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.Associated products were indicated.Information was provided that a non-qualified viscoelastic was used.The root cause cannot be determined for the reported complaint.Only half of the explanted lens was returned for evaluation.A dimensional inspection could not be conducted due to the extensive lens damage.Information provided in the initial report description that haptic damage was noticed when opened, and that the decision was made to continue to use the product.Because the returned lens portion had been implanted and then removed from the eye, it is not possible to confirm the condition of the lens upon customer receipt.In addition, a non-qualified viscoelastic was used.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
• MDR Report Key: 12061320
• Report Number: 1119421-2021-01269
• Device Sequence Number: 3926181
• Product Code: MFK
• UDI-Device Identifier: 00380652357838
• UDI-Public: 00380652357838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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 Expiration Date: 01/13/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.250
• Device Lot Number: 15006785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEALON PRO; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR