MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET; UNIT, PHACOFRAGMENTATION

Catalog Number	8065750918
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
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 the tube connecting the handpiece was not tight, resulting in water leakage during a cataract surgery.The product was replaced and the surgery was completed.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Current tracking indicates no adverse trend for this lot for this event.The returned irrigation/aspiration (i/a) manifold in a soft tray was visually inspected and no obvious defects were found.The sample was tested with the lab stock cassette and the other components using a calibrated console representing the current software version.The sample could tune with the ultrasonic handpiece, the 0.9mm air bypass tip (abs) tip and infusion sleeve.No leakage or detachment occurred during tuning with the handpiece.Fluid could irrigate and aspirate through the handpiece in the console i/a mold.The connectors and fittings on the i/a manifold were tightened firmly and securely on the cassette and handpiece.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Current tracking indicates no adverse trend for this lot for this event as the product met specifications.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 14631846
• Report Number: 1644019-2022-00439
• Device Sequence Number: 3739343
• Product Code: HQC
• UDI-Device Identifier: 00380657509188
• UDI-Public: 00380657509188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 8065750918
• Device Lot Number: 2494545H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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