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

Model Number	DFT015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, when placing the lens and passing it through the cartridge, it fractured and caused inconvenience to the doctor.The lens was removed.Additional information has been requested and received stating the lens was removed by making a larger incision of the cornea.The new lens was implanted the same day.
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).
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.The product was not returned.Information was provided that a qualified company cartridge was used with the lens.A non-qualified viscoelastic and a non-qualified handpiece were indicated.The root cause of the reported complaint was most likely related to a failure to follow the instruction for use (ifu).A non-qualified viscoelastic and handpiece were 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.Company recommends using the qualified company iol delivery system or any other company qualified combination."information was provided that the surgery was "concluded the same day but a lens equal to the fractured one must be obtained".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: 14744685
• Report Number: 1119421-2022-01320
• Device Sequence Number: 5176386
• Product Code: POE
• UDI-Device Identifier: 00380652421201
• UDI-Public: 00380652421201
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2026
• Device Model Number: DFT015
• Device Lot Number: 15201214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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: J AND J VISCOELASTIC AND HANDPIECE; MONARCH III CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male