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	Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.A product 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.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 patient experienced vision imbalance, and felt right eye was straining more since surgery.Clinical reason for explant was refractive surprise.The iol was exchanged for different model and diopter, company lens 4 months 13 days following the initial implant procedure.Target was not achieved during initial surgery but following iol exchange the patient was happy with the vision and issues were resolved with no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned positioned incorrectly in a lens case with the protective layer or barrier removed.Viscoelastic was observed on the lens.The optic was cut into pieces.Both optic portions had creaked and split optic damage near the optic central zone.One optic portion also has several scratched areas on the anterior surface.The other optic portion has an additional line of cracked and split damage between the center of the optic and the edge of the optic.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.The clinical reason provided was "refractive surprise".Each lens was subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The company 24.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a company 25.5 diopter (1.5 extended depth of focus) lens.This information that a company lens was replaced with a company lens that was 1.5 diopters higher would suggest that the replacement lens diopter was an improved selection for this patient's vision needs.File will be reopened when new information or the product is received.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: 19973690
• Report Number: 1119421-2024-01559
• Device Sequence Number: 8460718
• Product Code: POE
• UDI-Device Identifier: 00380652419185
• UDI-Public: (01)00380652419185(17)240930(11)191026(10)12740796
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 09/10/2025
• Device Model Number: DAT015
• Device Lot Number: 15098188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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: CLAREON VIVITY IOL.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; VISCOELASIC USED: HEALON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown