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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during set up for cataract vitrectomy combination of the surgery an ophthalmic operating surgical soft tip of cannula did not fit into the trocar to perform the infusion.Procedure was completed by replacing the tip and there was no patient harm.
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).
Additional Manufacturer Narrative
Additional information provided in sections d.9.H.3.H.6.And h.11.One opened soft tip cannula in a blister was received for the report of did not fit the trocar.Sample was visually inspected and found to be nonconforming, soft tip was folded over and pinched.Cannula od was dimensionally inspected and found to be conforming.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 visually condition of the soft tip folded over and pinched could result in the reported issue of soft tip did not fit in the trocar.How and when the soft tip became damaged could not be determined; therefore a root cause cannot be determined.The exact root cause for fit issue with the trocar and damaged soft tip is unknown, therefore, specific action with regards to this complaint cannot be taken.The exact root cause for this complaint 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: 18603985
• Report Number: 2523835-2024-00067
• Device Sequence Number: 9128444
• Product Code: HMX
• UDI-Device Identifier: 00380651495302
• UDI-Public: 00380651495302
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 8065149530
• Device Lot Number: 160W5X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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