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

Model Number	DFT015
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Inflammation (1932); Visual Disturbances (2140)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, micro-bubbles appeared on the surface of the implant.The patient's refraction was impaired with flickering and the implant was explanted and re-implanted with the same lens model 29 days following the initial procedure.Additional information was received, inflammatory deposit on implant was observed after the initial implantation of iol.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3.,h.6 and h.11.The lens was returned inside a small plastic specimen jar.Viscoelastic and blood were dried on the lens.The optic was torn (or cut) beginning at the optic edge and extending beyond the optic center.Splintering cracked damage occurred at the line of torn optic damage.The optic edge was broken.The broken piece of optic was not returned.The anterior optic surface has two areas that were cracked near the edge.Directly opposite these areas on the posterior surface, additional cracked optic damage was observed.The lens was cleaned with klrp (klotho-related protein) for further evaluation.One haptic was chipped on the gusset anterior surface and gouged on the distal anterior surface and edge.The reported micro bubbles were not observed.It is unknown if the areas of cracked optic damage were interpreted as the reported micro bubbles.Associated product information was not provided.The explanted lens was returned and severely damaged.The lens was cleaned.There were no micro bubbles observed.It is unknown if areas of the damaged optic were interpreted as the reported micro bubbles.Each lens was subjected to a 100 percent 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.Information was provided that the company 20.5 diopter lens was removed and replaced with another company 20.5 diopter lens.File will be reopened if new information is received.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: 20675600
• Report Number: 1119421-2024-02209
• Device Sequence Number: 8370226
• Product Code: POE
• UDI-Device Identifier: 00380652421249
• UDI-Public: (01)00380652421249(17)280813(11)230816(10)15695223
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Model Number: DFT015
• Device Lot Number: 15695223
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male