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

Catalog Number	8065751176
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
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 surgeon reported when using the handpiece during the ultrasound phase of a cataract procedure, the oscillation and aspiration stopped actuating.The procedure was completed without any problem after replacing the ultrasound tip.There was no harm to the patient.
Additional Manufacturer Narrative
One opened 30° ozil phaco tip in a tip wrench was received for the report of the phaco was unable to perform us oscillation and aspiration.The phaco tip was visually inspected and deemed nonconforming.There was clear foreign material present in the ab hole inside diameter causing occlusion.There was also wear on the back of flange, nut corners and threads consistent with use.The phaco tip with the foreign material in the ab hole inside diameter was sent to particle lab for analysis.The foreign material was analyzed using ft-ir and found the best match to be skin.The product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirms the phaco tip ab hole inner diameter was occluded with foreign material.The foreign material was analyzed using ft-ir and found the best match to be skin.How and when the phaco ab hole inside diameter became blocked with skin cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.The most likely source of the foreign material is from the surgical procedure.No specific action with regard to this complaint was taken because the source of the foreign material is not related to any manufacturing process.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).
Additional Manufacturer Narrative
The foreign material discovered in the distal tip id of the phacoemulsification was sent to particle lab for analysis.The foreign material discovered inside the distal tip was analyzed using fourier transform infrared (ftir) analysis and the elemental composition of the tan occluding material closest match was bovine albumin (protein).The exact identity is unknown.The manufacturer internal reference number: (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: 11609381
• Report Number: 2523835-2021-00120
• Device Sequence Number: 3262978
• Product Code: HQC
• UDI-Device Identifier: 00380657511761
• UDI-Public: 00380657511761
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2021

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 8065751176
• Device Lot Number: 13KH6F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 08/27/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/29/2021; 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM