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

Catalog Number	8065480120
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during cataract surgery cannula was blocked the procedure was completed on the same day without any 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
One opened ophthalmic cannula was received on a syringe for the report of the cannula was blocked.The returned sample was visually inspected and was found non-conforming with foreign material observed in the inner diameter of the cannula.The sample was then sent for particle analysis.The particle analysis found the foreign material to most closely match ophthalmic viscosurgical devices.A review of the device history record traceable to the possible lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The reported issue of the cannula was blocked is confirmed.The particle analysis found the foreign material to most closely match ophthalmic ophthalmic viscosurgical devices surgical device.Ophthalmic viscosurgical devices surgical device is not a material that is used in the cannula manufacturing process.How and when the ophthalmic visco surgical device got in the inner diameter of the cannula cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.Most likely root cause is ophthalmic viscosurgical devices surgical device got into the cannula during surgery and dried.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.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: 16252565
• Report Number: 2523835-2023-00039
• Device Sequence Number: 5273077
• Product Code: HMX
• UDI-Device Identifier: 00380654801209
• UDI-Public: 00380654801209
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 8065480120
• Device Lot Number: VD951A
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 09/22/2023
• 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