MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number	8065149530
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2025
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that during vitrectomy surgery, the physician had significant difficulty inserting the soft-tip cannula into the port.The physician cut off a bit of the tip to get it into the port, but when using the cutter, the port detached from the shaft of the cutter.It was also reported that when the physician switched to another soft-tip cannula, again unable to insert the tip into the port and had to open another new cannula.The surgery was completed on the same day after replacing with another new cannula with great difficulty.Patient impact has not been provided.Additional information has been requested and none received till date.
Additional Manufacturer Narrative
One opened 25 ga soft tip cannula in a blister with 2 trocar cannula hub assemblies, and a 25+20k probe was also in the bag was received for the report of difficulty putting the soft tip cannula into port.The returned sample was visually inspected and was found to be non-conforming as there was dried white foreign material on the cannula and the soft tip was cut.The sample was then dimensionally inspected for the cannula outer diameter and was found to be conforming.The sample was not functionally tested for fitting into a trocar as the soft tip was cut by the surgeon.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 returned sample was found to be visually non-conforming and dimensionally conforming.The visual condition of the soft tip being cut could result in the reported issue of difficulty putting the soft tip cannula into port.Since the soft tip was cut by the surgeon, a root cause cannot be determined.The cannula met specifications dimensionally.The exact root cause for fit issue with the trocar is unknown, therefore, specific action with regards to this complaint cannot be taken.All assemblies are 100% inspected by trained operators.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Common Device Name: CANNULA, OPHTHALMIC
• 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: 21404165
• Report Number: 2523835-2025-00134
• Device Sequence Number: 15533121
• Product Code: HMX
• UDI-Device Identifier: 00380651495302
• UDI-Public: (01)00380651495302(17)290430(11)240524(10)16UFJA
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 8065149530
• Device Lot Number: 16UFJA
• 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: 02/01/2025
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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: CONSTELLATION SURGICAL PROCEDURE PACK.
• Patient Sex: Unknown