MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE I/A HANDPIECE TIP; CATHETER, IRRIGATION

Catalog Number	8065752066
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the ultrasound tip (phaco emulsification tip) was too bent to use before surgery.The surgery was performed and completed after replacing the product with another one.The procedure type was unknown.There was no information about any patient impact.
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 d.9., h.3., h.6.And h.11.No technical inquiries were received from the customer.One opened phaco tip in a tip wrench was received for the report.The returned sample was visually inspected and was found to be nonconforming with phaco emulsification tip (phaco tip) cannula bent above the aspiration bypass hole, no wear was observed on threads, back of flange, and nut corners and consistent with threading on handpiece.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 nonconformance review of the reported lot.A nonconformance was found.This non-conformance could have potentially contributed to the reported event.An investigation was initiated in order to investigate the root cause of the bent phaco tip.The returned sample was found to be visually nonconforming with a bent phaco tip.How and when the phaco tip became bent could not be determined due to that the tip was loose in the bag without the protective wrench.However, because no wear was found on the threads a potential manufacturing related root cause could not be ruled out.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event.As the root cause and its origin are inconclusive, further investigation or manufacturing actions are not warranted at this time.However, an investigation has been initiated to determine root cause of the bent phaco tip.Additionally, nonconformance investigation was initiated for the related nonconformance identified on the nonconformance report.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance is removed from the lot and scrapped.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).

• Brand Name: I/A HANDPIECE TIP
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23070677
• Report Number: 2523835-2025-00987
• Device Sequence Number: 18641236
• Product Code: GBX
• UDI-Device Identifier: 00380657520664
• UDI-Public: (01)00380657520664(17)291231(11)250124(10)177W58
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910245
• 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
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752066
• Device Lot Number: 177W58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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
• Patient Sex: Unknown