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

Catalog Number	8065000341
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	05/15/2025
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 customer reported that during refractive lens exchange, femtosecond laser, bilateral surgery with an ophthalmic system and phacoemulsification tip.The tip was occluded with viscoelastic in pre phacoemulsification step, surgeon advanced to epi surgical step, occlusion failed to clear, and surgeon moved to sculpt surgical step and was able to clear occlusion and corneal burn occurred for which one suture was placed.The procedure was completed on same day.This report pertains to phacoemulsification tip involved in this reported event.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.Clinical information review: the patient experienced a ¿corneal burn, there was an occlusion reported, followed by a corneal burn, requiring a suture to seal the wound.The procedure completed but was scheduled as a ¿refractive intraocular lens (iol) exchange, with femtosecond laser, bilateral (both eyes) originally.Additional related information states that the¿ 30° hybrid phaco tip was used and then an occlusion tone was heard.The tip was occluded with viscoat in pre-phaco step.The surgeon advanced to epi surgical step, when the occlusion was not cleared.The surgeon advanced to ¿sculpt mode¿ and was able to clear occlusion.This is when corneal burn occurred.The surgeon placed 1 suture to seal the wound followed by a bandage contact lens (bcl).There was an email sent with a video.However, the video was not made available for review at this time.There were four (4) photos sent for review.Photo one (1) was a picture of the handpiece (hp) serialized information.Photo two (2) was a picture of the case metrics screen: overall total case time (00:18:42), total aspiration time: 00:03:19, estimated fluid aspirated 63 cc, is actuations: 12.Total phaco ultrasound (us) power: phaco energy: 9.6, cumulative dissipated energy (cde): 2.43, us total time: 00:00:1.5, equivalent average fp3: 32.3%, thermal sentry activation: 0, thermal sentry time one: 00:00:00.0./ 4d phaco: total time: 00:00:12.0, average: 20.9%, equivalent average fp3: 20.9% / torsional phaco: all (0%) / longitudinal phaco: total time: 00:00:03.2.Average¿43.5%, average fp3 24.%.Photo three (3) was a picture of the unity pak used during the case.Photo four (4) was a picture of an already prepped eye (complete with lid speculum).There was a conjunctival hemorrhage visible, but the orientation of the eye made to location difficult to determine.The operators manual states- company phacoemulsification handpieces integrate irrigation, aspiration, and emulsification to simultaneously maintain or inflate the anterior chamber, emulsify the lens, and aspirate the lens material from the eye.Together, with compatible tips and sleeves, they are used for ultrasonic applications.Ultrasonic tips are attached to the phacoemulsification handpieces to deliver mechanical energy to the lens, assisting in its removal through aspiration.Depending on the needs and technique preferred by the user, various styles of tips and tip bevels are available.Warning: to avoid the risk of reduced tip cutting performance, the presence of tip burrs, fluidic path obstruction, and foreign particle introduction into the eye, do not reuse or reprocess single use phacoemulsification tips.Do not use irrigation aspiration (ia) tips with phaco handpieces.Warning: to avoid the risk of a patient hazard, do not mismatch consumable components or use settings not specifically adjusted for particular consumable component combinations.Attach only compatible company consumables to the console or fluid management system (fms).Do not connect consumables to patient intravenous connections.Test for adequate irrigation and aspiration flow, reflux, and operation of each accessory prior to entering the eye.Inspect all handpiece cables and any cords on a regular basis and replace immediately if damage (for example, exposed wire, nicks in the insulation, deformation, etc.) is observed.Warning: 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.The user should not touch an activated ultrasonic handpiece tip, as injuries could occur.Inadvertent activation of functions that are intended for priming or tuning accessories while the accessory is in the eye can create a hazardous situation that could result in patient injury.To avoid the risk of shallowing or collapsing of the anterior chamber due to fluidic imbalance or poor fluidic response, perform the following checks: ensure there are no leaks in the irrigation or infusion line.Ensure the stream of fluid is present and strong.Ensure tubing is not occluded or kinked.Ensure the test chamber does not collapse after tuning.To avoid jeopardizing good fluidic response, test for adequate irrigation and aspiration flow prior to entering the eye.Occlusion and vacuum tones: the console emits different tones or sounds to indicate an occlusion or vacuum activity during operation.Note: occlusion tones can be turned off, but the vacuum tone cannot be turned off.Occlusion tones ¿ indicate the vacuum is near or at the preset limit and aspiration flow is reduced or stopped.There are 2 types of occlusion tones: an ia occlusion tone ¿ indicates an occlusion during aspiration only (no ultrasonic power).The tone is a lower, intermittent single beep.A phaco occlusion tone ¿ indicates an occlusion during the application of ultrasonic power.The tone is a higher, intermittent double beep.The phaco occlusion bell ¿ indicates there is no aspiration flow.Warning: to avoid the risk of significant temperature increases at the incision site and inside the eye, potentially leading to severe thermal eye tissue damage, avoid the following actions: high power settings / prolonged use corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.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.Attached photos and video were reviewed by the manufacturing site.Photo 1 shows a wrench, sleeve, and phaco tip broken at the aspiration bypass (ab) hole.Photo 2 & 3 shows the phaco tip in the wrench and the broken tip retained in the sleeve.Video shows broken tip being rotated.Reported issue is confirmed.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.While the root cause and its origin are inconclusive, the following factors outlined in the reported product¿s direction for use (dfu) and operator¿s manual could potentially contribute to an outcome similar to the reported event.It is highlighted in the operator¿s manual that to avoid the risk of significant temperature increases at the incision site and inside the eye, potentially leading to severe thermal eye tissue damage, avoid the following actions: high power settings / prolonged use.Also, to avoid the risk of a patient hazard, do not mismatch consumable components or use settings not specifically adjusted for particular consumable component combinations.Attach only compatible company consumables to the console or fluid management system (fms).Do not connect consumables to patient intravenous connections.Test for adequate irrigation and aspiration flow, reflux, and operation of each accessory prior to entering the eye.Inspect all handpiece cables and any cords on a regular basis and replace immediately if damage (for example, exposed wire, nicks in the insulation, deformation, etc.) is observed.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 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: 22186198
• Report Number: 1644019-2025-01819
• Device Sequence Number: 18243056
• Product Code: LRO
• UDI-Device Identifier: 00380650003416
• UDI-Public: (01)00380650003416(17)250831(11)240923(10)172EK0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 8065000341
• Device Lot Number: 172EK0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 09/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNITY CATARACT FMS PROCEDURE PACK.; UNITY VCS CONSOLE.; UNITY VISION SYSTEM, ACCE, ACTIVE SENTRY HP.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown