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

Catalog Number	8065752066
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
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 screw did not fit before cataract surgery.The surgery was completed after replacing the product with another one.No patient harm was reported.
Additional Manufacturer Narrative
One opened phaco tip in a wrench, in a blister was received.Sample was visually inspected and found to be nonconforming, threads were damaged.Slivers and nicks were observed on the threads.Wear observed on threads, back of flange, and nut corners consistent with threading on handpiece.The phaco tip threads were then functionally tested and were found to be nonconforming, as the tip would not fully thread on gage.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 complaint evaluation confirms that the tip would not be able to be threaded on a handpiece due to the threads were damaged.Since the product was returned opened, how and when the phaco threads became damaged cannot be determined from this evaluation and the root cause cannot be determined.Most likely cause for the damage is handling during threading.The exact root cause for the screw did not fit before surgery is unknown; therefore specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.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: 17912319
• Report Number: 2523835-2023-00524
• Device Sequence Number: 6653376
• Product Code: GBX
• UDI-Device Identifier: 00380657520664
• UDI-Public: 00380657520664
• 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): 01/16/2024

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: 153KHW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: CONST VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HP; HAND PIECE
• Patient Sex: Unknown