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

Model Number	SN6AT6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Blurred Vision (2137); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/24/2021
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that fourteen days following a cataract extraction with intraocular lens (iol) implant procedure, the patient developed endophthalmitis.An intracameral injection of a cephalosporin antibiotic was performed following surgery.Conjunctival inflammation, aqueous cell, hypopyon, and moderate vitreous inflammation were noted on exam.The patient reported soreness and cloudy vison.The patient was treated with an intravitreal injection of a glycopeptide/cephalosporin antibiotics, oral, and topical antibiotic, and topical non-steroidal anti-inflammatory medication.The symptoms have resolved.Additional information has been requested and received.

• 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
• MDR Report Key: 12746425
• Report Number: 1119421-2021-02057
• Device Sequence Number: 4489673
• Product Code: MJP
• UDI-Device Identifier: 00380652274661
• UDI-Public: 00380652274661
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 04/30/2022
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6U100
• Device Lot Number: 12538519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCAINE; BROMSITE; BROMSITE; BSS STERILE IRRIGATING SOLUTION; CEFUROXIME; CENTURION VISION SYSTEM; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; INTRACAMERAL INJECTION; INTREPID TRANSFORMER; LIDOCAINE GEL; MYDRIACYL; NEOSYNEPHERINE; POVIDONE IODINE 10%.; POVIDONE IODINE 5%; PREDNISOLONE; VIGAMOX
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 58 YR