MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Codes	Defective Device (2588); Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported during the intraocular lens implantation the lens was defective.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in b.5., d.5., and d.10 the manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, during surgery scratch on lens was noted.The surgery was completed with the standby lens and there were no complications or consequences to the patient additional information has been received stated that there was a patient contact, the lens was implanted and then explanted again.A replacement lens was implanted.Visual acuity and health of patient was not impacted.
Additional Manufacturer Narrative
The account indicated the use of a non-qualified cartridge and viscoelastic.The company 27.5 diopter is only qualified for use in the company cartridge.The qualified diopter range for the company cartridge is 10.0 - 25.0.The customer indicated the use of a qualified handpiece.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).The cartridge and viscoelastic indicated are not qualified for the lens model used.The company diopter is only qualified for use in the company cartridge.The qualified diopter range for the company cartridge is 10.0 - 25.0.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.The product was not available for evaluation.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 13666792
• Report Number: 1119421-2022-00396
• Device Sequence Number: 5303176
• Product Code: POE
• UDI-Device Identifier: 00380652421799
• UDI-Public: 00380652421799
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• 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,Followup
• Report Date (Section B): 09/15/2022

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: 04/19/2026
• Device Model Number: DFT315
• Device Lot Number: 15188841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 08/22/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 08/19/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED NON-COMPANY VISCOELASTIC
• Patient Sex: Unknown