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

Catalog Number	8065752917
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that, following cataract surgery with intraocular lens (iol) implantation, the patient was diagnosed with endophthalmitis.The surgery details were unknown.The patient was treated with an intravitreal antibiotic injection on two different days.The current patient¿s condition was unknown.Additional information has been requested, but none has been received to date.This report is pertaining five of six patients reported from the same facility.This report pertains to cassette involved in this reported event.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.The reported product was not received at the investigation site for evaluation.Clinical information review: the customer reported there were cases which required two (2) intravitreal antibiotic injections post-operatively (on different days).This investigation will serve as ¿patient five (5) of the six (6) reported with endophthalmitis.This patient who was scheduled for pars plana vitrectomy (ppv), additional information obtained states that there was ¿staphylococcus detected in the preliminary analyses of the collected samples.¿ there are multiple factors that could contribute to the occurrence of endophthalmitis.A patient¿s ocular flora or microorganisms that have colonized the surface structures (eyelids and conjunctiva) are the usual cause of infection, therefore isolating eyelids and eyelashes from the surgical field is crucial.The most common cultured microorganisms are gram-positive coagulase negative cocci (70%) with staphylococcus epidermis (s.Epidermis) the most prevalent.Deoxyribonucleic acid (dna) analyses of s.Epidermis strongly suggest that it is likely that commensal bacterial contaminating the anterior chamber at the time of surgery are responsible for most cases of endophthalmitis.According to the european society of cataract and refractive surgeons (escrs) and other reputable ophthalmic organizations, the most accepted practice to prevent is the topical use of povidone iodine 5% in the conjunctival sac before surgery.Antibiotics used days before surgery has been shown to decrease the bacterial load at the time of surgery.Povidone-iodine solution has broad antibiotic activity and has been shown to significantly decrease conjunctival and perilimbal flora.Meticulous prepping and draping of the patient before surgery are important as well, to isolate the eyelids and lashes from the surgical field.Finally, attempts should be made to decrease any postoperative patient risk factors, such as immunosuppression or systemic disorders that may affect the wound healing and the ability of the eye to ward off any inoculums of bacteria during cataract surgery.Intraoperative risk factors may be associated with an increased incidence of postoperative endophthalmitis.These include inadequate disinfection of the eyelid or conjunctiva, vitreous loss, or unplanned/unapparent ocular penetration.The system is a closed system.It is operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phacoemulsification handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phaco handpiece is a reusable device that must be reprocessed per the product dfu.There is no evidence that the design or performance of the system caused or contributed to this reported event of endophthalmitis.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information received, the investigation was unable to conclusively identify the root cause for the reported event as a product was not returned for evaluation.The root cause and its origin are inconclusive and further investigative, or manufacturing actions are not warranted at this time.No manufacturing-related deficiencies were found that potentially could have contributed to the complaint.No further investigative or manufacturing actions are warranted at this time.The manufacturing area operates in a controlled positive pressure environment and is continuously monitored to prevent entry of foreign material.Additionally, procedures are in place requiring all assembly room personnel to put on a hairnet, as well as a beard cover, when applicable, prior to entering the assembly area.These measures help prevent the introduction of foreign material into the product.Complaints are continuously monitored to identify product and/or process areas where debris/foreign material is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper and maintaining clean work areas.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.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 warranted at this time.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23691738
• Report Number: 1644019-2025-05224
• Device Sequence Number: 21102905
• Product Code: LRO
• UDI-Device Identifier: 00380657529179
• UDI-Public: (01)00380657529179(17)270731(11)250812(10)17L3U5
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752917
• Device Lot Number: 17L3U5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 08/12/2025
• 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: BSS STERILE IRRIGATING SOLUTION.; CENTURION VISION SYSTEM (ACTIVE SENTRY).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female