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

Catalog Number	8065752088
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An ophthalmologist reported the vacuum did not respond during a cataract procedure.The product was replaced twice still the vacuum did not respond.The procedure was delayed for two hours and then discontinued.The patient was sent to another clinic to complete the procedure seven days later.There was no harm to the patient.
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 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.The returned sample was visually and functionally tested and passed testing, no aspiration issues were found during testing.The root cause of the customer's complaint could not be established; the returned sample met specifications.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.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.No adverse trends have been observed associated with the reported product and event.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: 14165769
• Report Number: 1644019-2022-00298
• Device Sequence Number: 17399479
• Product Code: LRO
• UDI-Device Identifier: 00380657520886
• UDI-Public: 00380657520886
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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
• Report Date (Section B): 07/07/2022

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: 04/30/2023
• Device Catalogue Number: 8065752088
• Device Lot Number: 2481946H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: INFINITI VISION SYSTEM; TORSIONAL HANDPIECE; UNSPECIFIED CUSTOM PAK, HTX
• Patient Age: 76 YR
• Patient Sex: Female