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

Catalog Number 8065751577

Device Problems Difficult to Insert (1316); Mechanical Jam (2983)

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

Event Date 11/26/2020

Event Type  malfunction  

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 Description

A surgeon reported the chandelier tip could not be inserted through the trocar and it got stuck during a vitrectomy procedure.The product was replaced and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

A review of the device history record traceable to the lot number obtained from the device¿s radio-frequency identification (rfid) tag indicates that the product was processed and released according to the product¿s acceptance criteria.An opened illuminator was returned for evaluation.The illuminator was visually inspected and deemed nonconforming.The fiber has melted and deformed into an irregular shape.A dimension test was performed, the tapered fiber tip outside diameter was measured and deemed nonconforming.A functional fit check using the returned trocar was performed and deemed nonconforming.The tapered fiber tip did not pass through the returned trocar due to the melted condition.The complaint evaluation confirms the illuminator could not be inserted into the trocar due to the melted and deformed condition.How and when the fiber became melted cannot be determined from this evaluation.The most likely source of a melted fiber condition would be if the light source remains on and the fiber is out of the eye in air for a prolonged period of time.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All fiber optic light guide products are 100% visually inspected and light tested for transmittance and image by trained operators during manufacturing any nonconformance, such as the melted and deformed tapered fiber tip exhibited on the returned opened sample, is removed from the lot and scrapped.The manufacturer internal reference number is:(b)(4).

• Brand Name: FIBER OPTIC ILLUMINATOR
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10971383
• MDR Text Key: 220908101
• Report Number: 1644019-2020-00665
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K875005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 8065751577
• Device Lot Number: 2323488H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM