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	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during implantation of an intraocular lens (iol), a scratch was found on the lens optic after iol loading into the eye.The lens was removed and replaced with another lens and the procedure was completed on the same day.There was no patient harm.Additional information was requested.A questionnaire was received.
Additional Manufacturer Narrative
Product 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during implantation of an intraocular lens (iol), a scratch was found on the lens optic after iol loading into the eye.The lens was removed and replaced with another lens and the procedure was completed on the same day.There was no patient harm.Additional information was requested.A questionnaire was received.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is twisted in the gusset area and pointing out of the locking mechanism area of the lens case.The optic is split from the edge across the center of the lens.Multiple cracks are observed on the optic.The cracks may be interpreted as the reported complaint of a scratch found on the optic.Associated products were not provided.It is unknown if qualified products were used.The reported lens damage was observed.Multiple cracks are observed on the optic.The cracks may be interpreted as the reported complaint of a scratch found on the optic.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met alcon¿s release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.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: 13470242
• Report Number: 1119421-2022-00196
• Device Sequence Number: 17111611
• Product Code: MFK
• UDI-Device Identifier: 00380652357746
• UDI-Public: 00380652357746
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.205
• Device Lot Number: 15142523
• 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: 01/16/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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
• Patient Sex: Unknown