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

Model Number	DFT015
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Conjunctivitis (1784); Endophthalmitis (1835); Inflammation (1932); Fibrosis (3167); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, patient started complaining of complication and diagnosed with endophthalmitis.Additional information has been received and provided culture report which stated in grams staining (culture), many pus cells, few gram positive cocci in pairs & clusters were seen.And organism isolated (fluid) was staphylococcus epidermidis.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 provided in h.3., and h.10.Information was provided that the fluid culture identified staphylococcus epidermidis, which is part of the normal human microbiota.Previously submitted "fibrosis" fda patient code was sent in error and hence removed.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in a.1., b.2., b.5., b.7., d.6.A., e.4., h.3.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and provided the patient had vitreous inflammation, conjunctival inflammation, aqueous cell were seen, aqueous fibrin present.Vitrectomy was performed.It was mentioned that while injecting the lens, a small filmsy membrane was seen at the edge of the lens which was removed with a good viscoelastic at the end.The patient symptoms were improving.

• 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: 17333698
• Report Number: 1119421-2023-01269
• Device Sequence Number: 17796407
• Product Code: POE
• UDI-Device Identifier: 00380652421256
• UDI-Public: 00380652421256
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFT015
• Device Lot Number: 15372543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 09/05/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/11/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male