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

Catalog Number	8065751176
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during a cataract surgery metallic powder-like substance was left on the iris during surgery.Surgeon suspect foreign object was from the phacoemulsification handpiece, phaco tip, sleeve, or pack.There are no plans for surgery to remove the foreign material and the patient is scheduled for observation.
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.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).
Additional Manufacturer Narrative
The phaco tip was visually inspected was nonconforming, there was damage seen on the od below the ab hole and tip edge of the phaco.No foreign material was observed on the od or id of the phaco.There was wear on the threads consistent with use.Due to the reported event of a piece of metal exited the phaco a functional flow check was performed, the phaco was deemed conforming, no foreign material was observed exiting the phaco id and the flow was good exiting the tip.The piece of metal from the customer was sent to the particle lab.The foreign material was analyzed using micro ft-ir, the analysis indicates the best match to be titanium.The size of the particle.590" (1.5mm) is too large to exit the phaco id and the damaged seen on the tip is.0085" in length.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 the foreign material reported by the customer, identified as titanium.The source of the foreign material from this investigation is unknown and based on the size of the foreign material, however it is unlikely it came from the phaco id.Therefore, the root cause cannot be determined.No specific action with regard to this complaint was taken because the source of the foreign material is unknown.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
• 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: 14318016
• Report Number: 2523835-2022-00170
• Device Sequence Number: 4698155
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 03/31/2026
• Device Catalogue Number: 8065751176
• Device Lot Number: 13VRVW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INFINITI SURGICAL PROCEDURE PAK; INFINITI VISION SYSTEM; OZIL TORSIONAL HANDPIECE
• Patient Sex: Unknown