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

Catalog Number	8065752900
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that a thread-like fiber was found inside the patient's eye after cataract surgery with intraocular lens implantation.There was no information about patient impact.Additional information was received that the foreign material was removed from the patient's eye by performing additional surgery.The current condition of the patient was unknown.Additional information was received and confirmed that there was no impact to the patient.
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
Additional information provided in a.1., a.2., a.3a., b.5., b.7., h.2., and h.11.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that a thread-like fiber was found inside the patient's eye after cataract surgery with intraocular lens implantation.There was no information about patient impact.Additional information was received that the foreign material was removed from the patient's eye by performing additional surgery.The current condition of the patient was unknown.Additional information was received and confirmed that there was no impact to the patient.Additional information was received that patient condition was recovering.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A customer reported that something like a thread-like fiber was found inside the patient's eye after surgery.This may be fibers that have come out of a sleeve, so this product was reported as defective.The involved eye and the patient identifier are not available.The material is in the eye and could not be provided.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.Visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.At this time, this investigation will be processed for closure.The investigation reviewed the complaint history data for the reported lot number and found one complaint was reported for this product and event combination, including the file in question.The total number of similar complaints is within the action threshold for the product lot and event combination.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified, all corresponding production release specifications defined in the device master record were met.Complaints are reviewed and monitored for adverse trends on a monthly basis.No adverse trends have been observed associated with the reported product and event.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action is warranted at this time.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Contributing factors to foreign materials could be other surgical items utilized in conjunction with the reported product.The small parts kit is manufactured within an environmentally controlled area where all employees are required to wear protective clothing.Manufacturing equipment is cleaned and maintained on a routine basis.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• 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: 21074823
• Report Number: 1644019-2025-00078
• Device Sequence Number: 12453974
• Product Code: LRO
• UDI-Device Identifier: 00380657529001
• UDI-Public: (01)00380657529001(17)270131(11)240221(10)16JRNM
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• 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,Followup
• Report Date (Section B): 03/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752900
• Device Lot Number: 16JRNM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/22/2025; 03/06/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/12/2025; 03/30/2025
• Date Device Manufactured: 02/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female