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

Model Number	SN6AT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Loss of Vision (2139)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that, after intraocular lens implantation surgery, the patient's eye has developed endophthalmitis.The surgeon has performed intraocular lens implantation surgery on the both the eyes of the patient.The first eye progressed well whereas the second eye developed endophthalmitis and the prognosis was very poor.Additional information was requested but no further information is available.
Additional Manufacturer Narrative
The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided by the reporter for further investigation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that the patient presented with exacerbated intraocular inflammation, with hypopia that evolved into endophthalmitis.There was also additional medical intervention or hospitalization associated with the event.There was patient harm, blindness.Additional information was received stating that, the blindness was irreversible, with no recovery, even after intervention and treatment.
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.The product was not returned.All intraocular lenses (iols) are terminally sterilized with 100% ethylene oxide sterilization.The company uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17886774
• Report Number: 1119421-2023-01717
• Device Sequence Number: 7299149
• Product Code: MJP
• UDI-Device Identifier: 00380652249935
• UDI-Public: 00380652249935
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2024

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: SN6AT3
• Device Catalogue Number: SN6AT3.220
• Device Lot Number: 15494709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 12/07/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/12/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male