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

Catalog Number	8065752081
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that no vacuum was created during intraocular lenses implant (iol) implantation surgery.The surgery was completed after replacing the product with another one.There was no patient impact.
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
Corrected information provided in b.2., b.5.And h.11.Following submission of the initial report, upon further assessment it was determined that the cassette could be primed (no vacuum was created) does not meet criteria for reporting based on applicable medical device regulations.Hence this report does not meet a reportable device malfunction criteria.No further reports will be scheduled under mfg report num 1644019-2024-02741.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
It was determined that the information provided for this event no vacuum was created does not represent a reportable device malfunction and it is not likely that a recurrence would result in serious injury.The initial report was submitted in error.

• 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: 20703865
• Report Number: 1644019-2024-02741
• Device Sequence Number: 20885801
• Product Code: LRO
• UDI-Device Identifier: 00380657520817
• UDI-Public: (01)00380657520817(17)241130(11)221220(10)1585VA
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 11/30/2024
• Device Catalogue Number: 8065752081
• Device Lot Number: 1585VA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 12/20/2022
• 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: Unknown