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

Catalog Number	8065752082
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 that the irrigation failure occurred during a cataract procedure.The product was replaced with another one and the procedure was completed.There was no harm to the patient.
Event or Problem Description
The surgeon reported, anterior chamber shaping was compromised.
Additional Manufacturer Narrative
The customer did not retain the product lot information.Therefore, the device history records traceable to the reported procedure pack could not be reviewed.A sample was visually inspected and no obvious defects were detected.The sample was tested using a console.The fluidics management system primed and tuned with the handpiece, the 0.9 millimeter (mm) air bypass tip and infusion sleeve from the lab stock successfully.The root cause of the customer's complaint could not be established.The returned sample functioned, per specifications.After an investigation of this complaint, it has been determined, that this sample functioned, per specifications.Therefore, no corrective action is required at this time.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
• MDR Report Key: 11870017
• Report Number: 1644019-2021-00357
• Device Sequence Number: 14256905
• Product Code: LRO
• UDI-Device Identifier: 00380657520824
• UDI-Public: 00380657520824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752082
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: INFINITI VISION SYSTEM; INFINITI VISION SYSTEM