MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE LEGION ANTERIOR VITRECTOMY KIT; UNIT, PHACOFRAGMENTATION

Catalog Number 8065753056

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

An other health care professional reported that the trocar clamped to the spike during vitrectomy surgery.The surgery was completed on the same day after replacing the skewer with another one.There was no patient harm.

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).

Manufacturer Narrative

Product manufacturing site updated due to receipt of corrected product information.Manufacturer report number corrected and reported under mdr# 2481028 for manufacturer report number 1644019-2024-00777.The manufacturer internal reference number is: (b)(4).

Event Description

As a result of an internal review of the file, following submission of the initial report, it was determined that the information provided for this event ¿trocar clamped to the spike¿ (the event code was trocar product fit) does not represent a reportable device malfunction and it is not likely that a recurrence would result in serious injury.

Manufacturer Narrative

As a result of an internal review of the file, following submission of the initial report, it was determined that the information provided for this event ¿trocar clamped to the spike¿ (the event code was trocar product fit) 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.1644019-2024-00777.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGION ANTERIOR VITRECTOMY KIT
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• 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: 18501345
• MDR Text Key: 332745336
• Report Number: 2523835-2024-00027
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065753056
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/29/2024; 05/15/2024
• Supplement Dates FDA Received: 04/23/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1