MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 physician reported following an intraocular lens (iol) implant procedure, the patient had chronic endophthalmitis that led to explant the lens.The lens was sent out to pathology and it was positive for moderate growth of parvibaculum lavamentivorans.The lens was explanted and replaced with other lens in a secondary procedure.Additional information was received as the patient had vitreous inflammation, eye pain, light sensitivity, corneal edema, vitrectomy was performed.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 17118833
• Report Number: 1119421-2023-01103
• Device Sequence Number: 6611734
• Product Code: HQL
• UDI-Device Identifier: 00380655093313
• UDI-Public: 00380655093313
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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: 10/13/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.260
• Device Lot Number: 15108120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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: BROMSITE; LIDOCAINE; POVIDONE 5%; PRED FORTE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female