MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751178
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
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 physician reported an aspiration failure occurred during the ultrasound (us) phase of a cataract procedure.The product was replaced with another one and the procedure was completed.There was no harm to the patient.
Additional Manufacturer Narrative
One opened phacoemulsification (phaco) tip in a zip top bag was received.The phaco tip was visually inspected and deemed nonconforming.There was clear foreign material present in the distal tip inside diameter causing partial occlusion.There was also wear on the back of flange, nut corners and threads that is consistent with use.The phaco tip with the foreign material in the distal tip inner diameter (id) was sent to particle lab for analysis.The clear occluding foreign material inside the distal tip was analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir) analysis and the closest match was bovine albumin (protein).The exact identity is unknown.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The complaint evaluation confirms the phaco distal tip id was partially occluded with foreign material.The clear occluding foreign material was analyzed using ftir analysis and the best match was bovine albumin (protein); however the exact identity is unknown.Bovine albumin (protein) is not used in the manufacturing or packaging process of phaco tips.How and when the bovine albumin partially occluded in the distal tip id cannot be determined from this evaluation and a root cause for or the customer complaint issue cannot be determined.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.

• Brand Name: PHACO 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: 11899834
• Report Number: 2523835-2021-00181
• Device Sequence Number: 17031942
• Product Code: HQC
• UDI-Device Identifier: 00380657511785
• UDI-Public: 00380657511785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161794
• 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): 09/08/2021

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: 8065751178
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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