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

Model Number	DFT015
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
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.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 the cataract surgery with intraocular lens (iol) implant procedure, lens got trapped inside the cartridge.It was removed to have a better visualization, she realizes that the lens has broken.The surgery was completed by replacing with another iol on the same day.There was patient contact with the product however no patient harm reported.
Additional Manufacturer Narrative
The lens was not returned in a cartridge as described.The lens was returned positioned incorrectly in the lens case (wagon wheel).Solution was dried on the lens.One haptic was bent in the gusset and distal area.The other haptic was broken from the gusset area (returned).The optic was torn/split/cracked with multiple large portions of optic lens material missing (not returned).The associated cartridge was not returned for evaluation.The file indicated the use of a qualified associated cartridge and handpiece.The viscoelastic indicated is not qualified for the product combination used.The root cause for the reported complaint appears to be related to failure to follow the instruction 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 16156115
• Report Number: 1119421-2023-00087
• Device Sequence Number: 7396417
• Product Code: POE
• UDI-Device Identifier: 00380652421386
• UDI-Public: 00380652421386
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFT015
• Device Lot Number: 15295837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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 C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOELASTIC : BIOCELLULENT
• Patient Age: 63 YR
• Patient Sex: Female