MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON INFINITI SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/01/2021
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 physician reported the patient experienced an unspecified infection following a cataract procedure.The phacoemulsification tubing showed some doubtful growth however the patient¿s vitreous tap was negative.The patient was treated with antibiotics and steroids and the condition was improved.Additional information was requested; however, none has been received to date.This is the fifth of eight reports for this surgeon.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The customer did not retain the product lot information for this procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.A consumable is a single-use medical device provided to the customer in a sterile manner.An evaluation is conducted to ensure each fluidics management system (fms) meets customer, process, and regulatory requirements.Once the consumable is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation has taken into account the worst case to ensure all consumables meet all sterilization cycle parameters for acceptability prior to release.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12810522
• Report Number: 1644019-2021-00718
• Device Sequence Number: 5511279
• Product Code: LRO
• UDI-Device Identifier: 00380657520817
• UDI-Public: 00380657520817
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2022

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 Catalogue Number: 8065752081
• Device Lot Number: ASKU
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 01/12/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/03/2021; 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BSS STERILE IRRIGATING SOLUTION.; ENTOD BALANCED SALT SOLUTION.; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown