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

Catalog Number	8065752066
Medical Device Problem Codes	Incomplete or Inadequate Connection (4037); Priming Problem (4040)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2025
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
The physician reported that phacoemulsification tip (phaco tip) was loose and priming test failure occurred during calibration.The procedure type was unknown.The surgery was completed after replacing the product with another one.There was no information about patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3.And h.11.One opened phacoemulsification tip, in a wrench was received for the report of priming test issue, sample was visually inspected and found to be conforming.Functional thread check and functional occlusion flow check was performed and both were found to be conforming.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.The photo attached was reviewed by the manufacturing site.The photo shows two phaco tips in a wrench in a blister.The reported issue could not be confirmed.Based on the evaluation of the information and materials received, the investigation concluded that the root cause of the reported event is not determined as the returned sample was conforming for visual and functional testing.No further investigative or manufacturing actions are warranted at this time due to that the returned sample met specifications.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: 22334669
• Report Number: 2523835-2025-00704
• Device Sequence Number: 15734936
• 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: 06/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HAND PIECE.
• Patient Sex: Unknown