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

Catalog Number	8065752200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	01/31/2026
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 health care professional reported that there was suspected toxic anterior segment syndrome (tass) which was a significant intraocular reaction following a cataract surgery (with intra ocular lens implantation) in an elderly patient.The surgery completion details or current patient condition were unknown.Additional information has been requested but none received till date.This report belongs to the eighth of the nine patients reported with said adverse event from the same facility.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.No product has been returned to the investigation site for evaluation; therefore, the condition of the product could not be verified.The most common causes of toxic anterior segment syndrome (tass) are identified as follows in order of prevalence: inadequate flushing of phaco, irrigation/aspiration handpieces and cannulated equipment, use of enzymatic cleaners and detergents, use of reusable cannulas, inadequate cleaning of instruments, use of preserved epinephrine, reuse of single use devices, use of tap water with no sterile water final rinse, inadequate personnel or trays to allow proper preparation of instruments, no immediate cleaning allowing ophthalmic viscoelastic device (ovd) and surgical solutions to dry on instruments, use of preserved medicines in the eye, reuse of tubing for flushing, latex bulbs for irrigation, not training, no terminal sterilization, instruments stored on towels, touching of intra ocular lens or patient contact areas of instruments with gloved hands, off-label use of lidocaine gel, poor instrument maintenance, autoclave residue, rust, particulates, lint, use of powdered gloves, additives added to balanced salt solution against directions for use (dfu) , improper use of prep solutions, detergents and cleaners, failure to follow manufacturer¿s directions for use, including no air flush, use of unapproved enzymatic cleaners, use of postoperative ointment in clear corneal cases, povidone-iodine placed in the eye at the end of procedures, incorrect concentration of detergents and enzymatic cleaners.The phacoemulsification systems are closed systems.They are operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).The proper cleaning and sterilization of ophthalmic surgical instruments can help prevent the occurrence of tass.These findings continue to validate the need to follow the recommendations detailed in the dfus, association of perioperative registered nurses (aorn) recommended practices, and the american society of cataract and refractive surgery (ascrs) tass task force guidance document.There are multiple factors that could contribute to the occurrence of reported event.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.No cultures were taken of the patient.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.There is no evidence that the design or manufacturing of the equipment contributed to the reported event.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 available information and no materials received for product evaluation, the root cause of this tass event is inconclusive.No further investigative or manufacturing actions are warranted at this time due to the product not being returned to the manufacturing site for testing.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: 24596748
• Report Number: 1644019-2026-01501
• Device Sequence Number: 9605937
• Product Code: LRO
• UDI-Device Identifier: 00380657522002
• UDI-Public: (01)00380657522002(17)270430(11)250523(10)17ET1F
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 8065752200
• Device Lot Number: 17ET1F
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 05/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Unknown