MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INTREPID TRANSFORMER; UNIT, PHACOFRAGMENTATION

Catalog Number	8065752885
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
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 that an ophthalmic tip was found to be broken before a cataract surgery.The surgery was performed and completed after replacing the product with another one.
Additional Manufacturer Narrative
One opened disposable ia handpiece, was received for the report of tip of product found broken the returned sample was visually inspected and found to be nonconforming.The grey irrigation tip's cannula was observed to be broken a little before cannula enters into the hub above the molded plastic.No lot number was identified with this complaint; therefore, a device history record review, complaint history review, and non-conformance review could not be conducted.The returned sample was found to be nonconforming for visual inspection, associated with the reported event, therefore the tip of product found broken as described in the complaint was confirmed.How and when the broken irrigation/aspiration tip occurred cannot be determined from this evaluation, and a root cause could not be determined.The most likely root cause is handling at any point after the i/a tip was shipped from the manufacturing site.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All disposable i/a tips are 100% visually inspected prior to being released from the manufacturing facility.Any non-conformances found are removed from the lot and scrapped.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: INTREPID TRANSFORMER
• 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: 18062996
• Report Number: 2523835-2023-00608
• Device Sequence Number: 7427539
• Product Code: HQC
• UDI-Device Identifier: 00380657528851
• UDI-Public: 00380657528851
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121555
• 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): 02/02/2024

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: 8065752885
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown