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	05/04/2022
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 aspiration was poor during ultrasound phase of a cataract surgery.The product was replaced and the surgery was completed.There was no patient harm.
Additional Manufacturer Narrative
One opened phaco tip in a zip top bag was received.The phaco tip was visually inspected and deemed non-conforming.There was damage on the outer diameter (od) and the cannula was slightly bent.No obstructions were observed in the proximal, distal identification (id's) and aspiration bypass (ab) hole.A functional flow check for occlusion was performed and deemed conforming.A good flow exiting the tip was observed.Wear on the nut corners were consistent with use.Wear on threads that was consistent with threading on a handpiece.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The complaint evaluation does not confirm the report of the phaco tip with poor aspiration during surgery.The returned sample was found to be conforming for all visual and functional testing associated with the are reported event of occlusion.Unrelated to the reported event, the complaint evaluation confirms the phaco outer diameter was damaged and the cannula bent.How and when the damage occurred cannot be determined, and a root cause for the damaged and bent phaco tip cannot be determined from this evaluation.The most likely root cause is handling during use.No action was taken for the report of occlusion as the sample was functionally conforming and an exact root cause for the damaged and bent condition could not be determined.All phaco tips100% 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: 14521845
• Report Number: 2523835-2022-00191
• Device Sequence Number: 15091124
• 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): 09/02/2022

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 Catalogue Number: 8065751176
• Device Lot Number: ASKU
• 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: 05/15/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown