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	05/26/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that the phacoemulsification (phaco) tip was found bent during the calibration step of surgery.The type of surgery was unknown.The surgery was completed by replacing the product.There was no report of patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One opened phacoemulsification (phaco) tip, in a wrench was received.Sample was visually inspected and found to be nonconforming with phaco was bent at cone to cannula transition area.Wear observed on threads, back of flange, or nut corners, 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 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.Attached photo was reviewed by the manufacturing site.The photo shows two phaco tips in a wrench in a blister.Reported issue cannot be confirmed from photo.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.The returned sample is visually non-conforming with the phaco tip bent; therefore, a bent phaco tip was confirmed; however, how and when the phaco tip became bent could not be determined.Most likely root cause is handling during placement of the phaco tip onto the handpiece.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).

• 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: 22329482
• Report Number: 2523835-2025-00702
• Device Sequence Number: 8301044
• Product Code: GBX
• UDI-Device Identifier: 00380657520664
• UDI-Public: (01)00380657520664(17)270831(11)220908(10)1511AK
• 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): 09/25/2025

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: 1511AK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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