MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INFINITI VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751176
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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 customer reported that the ultrasound tip was clogged and aspiration failure occurred.The product was replaced and the surgery was completed.There is no patient harm.
Additional Manufacturer Narrative
One opened phaco tip in a zip top bag was received, for the report of there was a clogged us with aspiration failure.The phaco tip was visually inspected and deemed conforming.Wear on the threads, back of flange and nut corners were consistent with use.No occlusions observed.A functional flow check for occlusion was performed and deemed conforming.A good flow exiting the tip was observed.Even though no lot number was identified with this complaint.Our products are processed and released according to the product¿s acceptance criteria.The complaint evaluation does not confirm the report of the phaco tip clogged us and aspiration failure.The returned sample was found to be conforming for all visual and functional testing associated with the reported event.Therefore, a phaco tip did not work as described in the complaint was not confirmed.And a root cause cannot be determined, for the complaint as described by the customer.No action was taken as the phaco tip was manufactured to specification.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: INFINITI VISION SYSTEM, HANDPIECE TIP
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 11682177
• Report Number: 2523835-2021-00136
• Device Sequence Number: 14326409
• Product Code: HQC
• UDI-Device Identifier: 00380657511761
• UDI-Public: 380657511761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 8065751176
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1