MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON FIBER OPTIC ILLUMINATOR; LIGHT, SURGICAL, FIBEROPTIC

Catalog Number	8065751577
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
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 cutting of the trocar was poor during vitrectomy surgery.The surgery was completed on the same day after replacing the product with another one.There was no patient harm.
Additional Manufacturer Narrative
One opened trocar assembly in a small parts tray (smpt) was received for the report.Sample was visually inspected and found to be nonconforming, damaged blade tip/bent tip and point broken off tip.Surgical material was observed on blade.Penetration testing could not be performed due to the damage of the sample.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The exact root cause could not be determined from the investigation performed.The damage to the returned sample is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of cutting of the trocar was poor during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformances, such as damaged tips, are removed from the lot and scrapped.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 further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: FIBER OPTIC ILLUMINATOR
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; industrial park muka kuning; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; industrial park muka kuning; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19613388
• Report Number: 9681121-2024-00026
• Device Sequence Number: 15009805
• Product Code: FST
• UDI-Device Identifier: 00380657515776
• UDI-Public: 00380657515776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K875005
• 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): 10/01/2024

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 Catalogue Number: 8065751577
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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