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

Catalog Number	8065752086
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported phacoemulsification tip was no longer aspirating, the surgeon had to urgently close the eye with a suture and had almost no anterior chamber during a cataract procedure.A fragment of eye nucleus remained in the anterior chamber because it was impossible to emulsify and aspirate it.There was no report of patient harm.
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
No sample was received, however, the reported lot number was expired on the procedure date.The lot number provided indicated the product was used beyond its expiry date.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of a pak label, the reported product and lot information is confirmed.A sample was not returned and a review of the lot number provided indicated the product was used beyond its expiry date.No specific action with regard to this complaint was taken by the manufacturing location because the complaint sample exceeded its expiration date and should not have been used.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 additional action is required at this time.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: 15072269
• Report Number: 1644019-2022-00581
• Device Sequence Number: 5489465
• Product Code: LRO
• UDI-Device Identifier: 00380657520862
• UDI-Public: 00380657520862
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/20/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 8065752086
• Device Lot Number: 1740496H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2015
• 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: INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown