MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065751510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that after a cataract surgery patient experienced inflammation (fibrin) and endophthalmitis.Patient was given with an antibacterial agent and the condition was improving.It was informed that the patient was in contact with surgical procedure packs, viscoelastics, ophthalmic phacoemulsification tip, ophthalmic phacoemulsification handpiece and irrigation/aspiration tip.Additional information was received clarifying the surgeon confirmed the event was tass (toxic anterior segment syndrome).
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).
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of inflammation post op, toxic anterior syndrome (tass), and medical intervention; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A review of the sterilization records indicates that the product was sterilized and released according to the product's acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All irrigation/aspiration (i/a) tips are 100% visually inspected prior to being released from the manufacturing facility.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13867697
• Report Number: 2523835-2022-00106
• Device Sequence Number: 4715833
• Product Code: KYG
• UDI-Device Identifier: 00380657515103
• UDI-Public: 00380657515103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 04/30/2023
• Device Catalogue Number: 8065751510
• Device Lot Number: 13XW21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: CENTURION SURGICAL PROCEDURE PAK; CONSTELLATION SURGICAL PROCEDURE PAK; CONSTELLATION VISION SYSTEM; CONSTELLATION,TABLETOP; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; HOYA XY1AT4; INFINITI VISION SYSTEM, HANDPIECE TIP; MONARCH III IOL DELIVERY SYST; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OZIL TORSIONAL HANDPIECE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female