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

Catalog Number	8065750280
Medical Device Problem Codes	Break (1069); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported the phacoemulsification (phaco) tip blocked during the nucleus removal phase and two shower/plumes of tiny silvery fragments came during the cataract procedure.There were no associated complications or symptoms on one day and one week post operation.Additional information was requested; however, none has been received to date.
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
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from the reporter who indicated the foreign material (similar to glitter) was not removed during the same procedure from the patient's right eye as it was stuck to the iris despite irrigation/aspiration.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; however, the attached customer photos confirm the foreign material in the eye, however it was not confirmed of where the foreign material originated.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The customer photos confirms the foreign material; however the because the sample of the foreign material was not returned the source and identity of the foreign material could not be identified.The report of phacoemulsification tip blocked was not confirmed due to a sample was not received and no lot number was provided, therefore the root cause for this 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 phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.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 further actions are required.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: 13028130
• Report Number: 1644019-2021-00839
• Device Sequence Number: 16575908
• Product Code: LRO
• UDI-Device Identifier: 00380657502806
• UDI-Public: 00380657502806
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2022

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 Catalogue Number: 8065750280
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 03/14/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 12/20/2021; 03/25/2022
• 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
• Patient Sex: Female