MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY CATARACT FMS PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065000342
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that phacoemulsification wound burn occurred at an unknown timing.The surgery details were unknown.There was no report of patient condition.Additional information was received that obstruction of flow occurred which lead to phaco wound burn for cataract with lens implant surgery and the wound was sutured.This report pertains to phacoemulsification tip involved in this reported event.
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.
Additional Manufacturer Narrative
No technical inquiries were received from the customer.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.Clinical information review: this patient has a cataract listed as ¿2-3 nuclear sclerosis (ns) and +2 cortical.¿ the case was scheduled for cataract extraction with intraocular lens (iol).Eye is unknown.The customer reported first an occlusion issue, which was followed by a phaco wound burn where sutures were required to seal the wound.Astigmatism was listed as the surgical outcome.Suture removal still needs to be done.Additional related information was requested but none has been provided to date.Corneal thermal injuries are typically related to excessive heat generated by the phacoemulsification (phaco) tip due to insufficient aspiration flow, extended energy application, or combination of both.The operators manual states ¿handle phaco handpieces with care.They must be at room temperature and dry just before use.Immediately following surgery, thoroughly clean the handpiece (see the handpiece directions for use (dfu) for cleaning information).Note: use viscoelastic (ovd) as appropriate for individual technique and experience level.When finished with the ovd, ensure it is sufficiently removed.Warning: to avoid excessive heating and potential thermal injury to adjacent eye tissues, ensure the irrigation sleeve is properly seated on the tip.To ensure sufficient volume of irrigating solution for the procedure, monitor the level before and during the procedure.To avoid spillage of irrigating solution, ensure that the maximum capacity of the drain container is not exceeded as this could cause a hazardous situation to the patient.¿ ¿warning: to avoid the risk of thermal eye tissue damage, ensure the appropriate profile and system settings are acceptable prior to starting the procedure.This may include surgical parameters like flow rates or limits, foot controller button configuration, sound volume, or language or default units of measure preferences.To avoid the risk of significant temperature increases at the incision site and inside the eye during phacoemulsification, potentially leading to severe thermal eye tissue damage, avoid the following: low vacuum limits, low flow rates, high power settings.Extended power usage, power usage during occlusion conditions (beeping tones), insufficient aspiration of viscoelastics prior to using power, excessively tight incisions, and prolonged use.To minimize fragments and turbulence, use appropriate technique and settings.To avoid the risk of excessive heating, operate the accessory (at 70% duty cycle) for a maximum of 10 seconds (for example, 10 seconds on and 4 seconds off).¿ ¿the thermal sentry feature helps to decrease wound heating effects by temporarily decreasing ultrasonic power level by monitoring power level and flow conditions.The sensitivity of this feature is adjustable to tailor the feature to individual technique and conditions.Warning: to avoid a risk of patient injury, do not inadvertently activate prime or tune accessories while the device is in the eye.Do not use phacoemulsification with occluded tubes.In the event of persistent loss of aspiration during operation, remove phaco power via the foot controller.To avoid mechanical and thermal tissue damage, do not direct ultrasonic energy toward non-lens material, such as the iris or capsule.Do not use a phacoemulsification accessory with a loose tip.To avoid a potential patient hazard or equipment damage, do not touch the accessory tip with any solid object while active.However, during any ultrasonic procedure, metal particles may result from inadvertent touching of the tip with a second accessory or ultrasonic energy causing micro abrasion of the tip.To avoid the risk of excessive heating or potential thermal injury to adjacent eye tissues, do not use phaco handpieces in the absence of irrigation flow or the absence or reduced aspiration flow.¿ literature provides insight on this issue: "in manual small incision cataract surgery (msics), the occurrence of intraoperative complications is a recognized concern that can impact both surgical outcomes and patient safety.Msics is widely practiced as a cost-effective alternative for cataract extraction, especially in resource-limited settings where access to phacoemulsification may be limited.However, it is important to acknowledge that msics is not entirely risk-free.Complications during the surgery can arise due to factors such as surgeon experience, surgical technique, instrument handling, and patient-specific anatomical variations.Common complications encountered in msics include posterior capsule rupture, corneal burns, iris trauma, wound-related issues, vitreous loss, and anterior chamber hemorrhage.It is crucial for surgeons to have a comprehensive understanding of the background and potential risks associated with these complications.This knowledge allows them to proactively implement preventive strategies, optimize surgical outcomes, and prioritize patient safety during msics procedures.Ongoing efforts in the field of cataract surgery aim to improve outcomes by advancing surgical techniques, refining equipment, and enhancing postoperative care.Through research and innovation, the goal is to minimize complications and achieve optimal visual outcomes for individuals undergoing cataract surgery." clinical evaluation has been reviewed.No contributing factor has been identified.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 investigation conducted a non-conformance review of the reported lot number.No deviations 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 identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.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: UNITY CATARACT FMS PROCEDURE PACK
• 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: 23826248
• Report Number: 1644019-2025-05532
• Device Sequence Number: 8954220
• Product Code: LRO
• UDI-Device Identifier: 00380650003423
• UDI-Public: (01)00380650003423(17)270331(11)250409(10)17C9HR
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 8065000342
• Device Lot Number: 17C9HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 04/09/2025
• 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: HAND PIECE; UNITY VCS CONSOLE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown