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

Model Number	TFNT30
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens was scratched during implantation and then it was removed and replaced with same model lens.There was no patient harm.The patient was not hospitalized in response to the event.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge, an unspecified company handpiece, and a qualified viscoelastic were indicated.The product investigation could not identify a root cause for the reported complaint.Only the empty lens carton was returned.The file indicated that the company (1.50 cyl.) 21.5 diopter (add power +2.2/+3.2) lens was replaced with an identical lens model and diopter.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 15622227
• Report Number: 1119421-2022-02203
• Device Sequence Number: 12379680
• Product Code: MFK
• UDI-Device Identifier: 00380652390002
• UDI-Public: 00380652390002
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: 07/31/2023
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.215
• Device Lot Number: 12646774
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2018
• 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; MONARCH III IOL, CARTRIDGE D; MONARCH IOL, INJECTOR, UNSPECIFIED
• Patient Age: 60 YR
• Patient Sex: Female