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

Catalog Number	8065751614
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that the vitrector handle came apart and hard air sound noise was observed during vitrectomy surgery.The surgery was completed after replacing the product with new one.There was no patient harm.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report; therefore, the condition of the product could not be verified.A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the 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 probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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).
Additional Manufacturer Narrative
Following submission of the initial report, it was determined that the information provided for this event ¿the vitrector handle came apart and hard air sound noise was observed¿ (probe, vit - no reportable malfunction) 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.No further reports will be scheduled under mfg report num 1644019-2023-00733.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information was updated in d.4.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 17169748
• Report Number: 1644019-2023-00733
• Device Sequence Number: 12405721
• Product Code: LRO
• UDI-Device Identifier: 00380657516148
• UDI-Public: (01)00380657516148(17)240831(11)220913(10)150N4F(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/23/2024

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: 08/31/2024
• Device Catalogue Number: 8065751614
• Device Lot Number: 150N4F
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 08/26/2024; 09/24/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 09/22/2023; 09/23/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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