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

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.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.Information was provided that the a company lens 22.0 diopter, (1.5 extended depth of focus) lens was replaced with a third party, 22.0 diopter, monofocal lens model.The product was not returned for evaluation.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Following the cataract surgery with intraocular lens (iol) implant procedure, the patient expressed that the light spreading when looking at the light source was resolved however complained of blurry vision when she sees a distance of more than 1 meter.The patient's visual acuity was 0.4.Additional information has been received and stated that, previously reported product serial number was wrong and correct serial number was provided.
Additional Manufacturer Narrative
Correction g.3: supplemental medical device report (smdr) # 01 is being filed to correct the g.3 date on the initial report, filed earlier.Incorrect date of 20-sep-2022 is being corrected to 17-nov-2022.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the non-company lens case inside a small plastic bag.Solution was dried on the lens.The optic was cut into three pieces.One haptic was cut from the optic at the gusset area.The haptic was returned in the lens case.A power and resolution test could not be conducted with the returned lens due to the extreme lens damage.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.Associated product information was not provided.The explanted lens was returned cut into several pieces, typical of damage created to help facilitate a lens removal from the eye.A power and resolution retest could not be conducted due to the extremely damaged returned condition.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.The exchange of a multifocal company lens to a monofocal (diopter unknown) may suggest that the final replacement lens model was an improved selection for this patient's vision needs or preferences.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: 15967388
• Report Number: 1119421-2022-02633
• Device Sequence Number: 20221279
• Product Code: POE
• UDI-Device Identifier: 00380652421270
• UDI-Public: 00380652421270
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2023

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: 05/10/2026
• Device Model Number: DFT015
• Device Lot Number: 15201224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/09/2023; 02/08/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/10/2023; 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: THIRD-PARTY SINGLE-FOCAL IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown