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 Code	Visual Impairment (2138)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and handpiece.Two viscoelastics were indicated.Only one of the two viscoelastics is qualified for this product combination.The product investigation could not identify a root cause for the reported complaint.The explanted lens has not returned.Follow up was provided that indicated the implantation of the company lens was on (b)(6).Visual impression post-op 0.8p.However, the patient was unable to cope, and sensory adaptation problems possible.The lens was explanted on (b)(6).The very fibrin-fixed haptic could not be removed during explantation without major manipulation.The surgeon chose to cut the haptic and leave in the periphery.The hcp indicated that from a medical perspective, no impairment was expected and no further operations or medication would be necessary.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure,lens was explanted at initial procedure due to temporal haptics cannot be mobilized.The iol was cut in the middle and removed.The temporal haptics remains in the capsular bag and do not interfere.Surgery was completed with back up lens.There was no patient harm.Additional information was received stating fibrin-fixed haptic left in the periphery.Additional information was received stating lens was explanted at secondary procedure, was unable to cope, and sensory adaptation problems possible.

• 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: 19984248
• Report Number: 1119421-2024-01576
• Device Sequence Number: 4551531
• Product Code: POE
• UDI-Device Identifier: 00380652421263
• UDI-Public: (01)00380652421263(17)280710(11)230713(10)15675664
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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 Model Number: DFT015
• Device Lot Number: 15675664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/14/2024
• Date Device Manufactured: 07/13/2023
• 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: ARGON VISC 2.0.; CENTURION VISION SYSTEM ACTIVE SENTRY HANDPIECE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male