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

Catalog Number	8065751577
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that tip of chandelier was coarse during cataract/vitrectomy combination surgery.The surgery was successfully completed after replacing the product with another one.There was no 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
One opened chandelier was received.The returned sample was visually inspected and found to be non-conforming, the fiber of the chandelier was observed to be melted, with tip appearing to be misshaped.A dimensional inspection was performed for fiber diameter and was found non-conforming.Finally, a functional fit check was performed and found non-conforming as product did not fit in a conforming (stock) trocar sample.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be nonconforming visually for a tip melted, therefore the tip of the chandelier was melted and unusable, which can be perceived as the fiber tip was coarse and had difficulty entering trocar.How and when the tip became melted cannot be determined from this evaluation; therefore, a root cause could not be determined.The most likely source of the 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 during manufacturing.Any nonconformance, such as the melted tip exhibited on the returned opened sample, is 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; 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: 19287713
• Report Number: 1644019-2024-01003
• Device Sequence Number: 8693546
• 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): 08/19/2024

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): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown