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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the customer stated that vision was still blurry, the clinical reason was minimal improvement with refraction.The iol was explanted and exchanged in as secondary procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Solution was dried on the lens.The optic has a medium sized scratch in the central optic zone on the posterior side of the lens.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stated that patient had increased halos and glare.Even after exchange with non-company multifocal lens, patient's condition was not resolved, the vision was still blurry and there was possibility of astigmatism.
Additional Manufacturer Narrative
Information was provided that indicated the use of a qualified cartridge and handpiece.A non-qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint of "vision still blurry, explant".The explanted lens was not returned for an evaluation.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Updated information was provided.The questionnaire indicated that in the surgeon's opinion the patient was unable to tolerate multi-focal lens due to blurry vision, increased halos, glare.The company 19.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company monofocal lens.Replacing a multifocal lens with a monofocal lens would suggest that the replacement lens model was an improved selection for this patient's needs.Also noted, a non-qualified viscoelastic was used in the cartridge.The instruction for use (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 intraocular lens (iol) delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING 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: 16724296
• Report Number: 1119421-2023-00642
• Device Sequence Number: 7989438
• Product Code: POE
• UDI-Device Identifier: 00380652424615
• UDI-Public: 00380652424615
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: DAT015
• Device Lot Number: 15235407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 07/24/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/19/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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: AMVISC; LENS LOADING FORCEP; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female