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

Catalog Number	8065752088
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.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 during a cataract surgery metallic powder-like substance was left on the iris during surgery.Surgeon suspect foreign object was from the phacoemulsification handpiece, phaco tip, sleeve, or pack.There are no plans for surgery to remove the foreign material and the patient is scheduled for observation.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Based on our current tracking, there are no adverse trends for this reported complaint.A customer reported that some piece of metal came in the eye.A wet intrepid plus fluidics management system (fms) was returned.The collected fluid from the cassette and drain bag was filtered and separated.The filters were placed into petri dishes and were sent to the particle lab for further investigation.Microscopic examination showed numerous reflective particles.The reflective particles were isolated and analyzed using the hitachi scanning electron microscope (sem) equipped with an edax energy dispersive x-ray spectrometer (eds).The elements found along with the visual characteristics suggest the dark particles are a titanium alloy.A review of the consumable components indicated the cassette and tubing manifolds are not manufactured with titanium alloy and would not have originated from a part manufactured at this manufacturing site.The particles would not have generated from the manufacturing process.The root cause of the customers complaint could not be conclusively determine the source of the titanium alloy.Titanium alloy is not material purchased or used in the manufacturing process.No action will be taken as manufacturer does not manufacture a component with titanium.Based on our current tracking, there are no adverse trends for this reported complaint.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: 14332431
• Report Number: 1644019-2022-00347
• Device Sequence Number: 17289931
• Product Code: LRO
• UDI-Device Identifier: 00380657520886
• UDI-Public: 00380657520886
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 8065752088
• Device Lot Number: 2480197H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: HANDPIECE TIP.; INFINITI VISION SYSTEM.; OZIL TORSIONAL HANDPIECE.
• Patient Sex: Unknown