MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME; CYSTOTOME

Catalog Number	8065426620
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
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 during the cataract surgery, surgeon noticed that a burr tip of blade.The surgery was resumed and completed after replacing the product with another one.No patient harm was reported.
Additional Manufacturer Narrative
Received one opened, c & c cannula, in a bag was received for the report of a burr tip during surgery.Sample was visually inspected and found to be nonconforming, tip of the cannula is dubbed/bent.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The returned sample is visually nonconforming with the tip of the cannula bent, which could have been perceived as a burr.How and when the tip of the cannula became bent could not be determined and a root cause could not be determined.The exact root cause for the damaged cannula sample is unknown, therefore specific action with regards to this complaint cannot be taken.All assemblies are 100% inspected by trained operators.Any nonconformance, such as the damaged tip exhibited on the returned opened sample is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME
• Common Device Name: CYSTOTOME
• 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: 18036202
• Report Number: 2523835-2023-00594
• Device Sequence Number: 8199413
• Product Code: HNY
• UDI-Device Identifier: 00380654266206
• UDI-Public: 00380654266206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 03/18/2024

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: 8065426620
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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