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

Catalog Number	4200200001
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
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 customer reported that an ophthalmic operating cannula was used during the surgery.The cannula was found to be clogged.The procedure was completed on the same day.There was no report of patient harm.Additional information has been requested and none received till date.
Additional Manufacturer Narrative
One opened c&c cannula in tip protector case with lid, in a bag was received for the report of clogged needle.Sample was visually inspected and found to be nonconforming, foreign material in the cannula id at the hub end was observed.Sample was sent to particle lab for analysis and was found to best match epoxy resin.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 complaint evaluation confirms the reported issue of clogged needle.The particle analysis found the foreign material best match to be epoxy resin.The cannula assembly is a component that is received at the manufacturing site from an external supplier.The root cause of the epoxy resin in the cannula id in hub end is related to the supplier¿s manufacturing process.An investigation has been initiated in order to further investigate the foreign material in the cannula id.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.This inspection includes visual inspection for foreign material.Any non-conformances found are 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, 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: 18976807
• Report Number: 2523835-2024-00440
• Device Sequence Number: 17809018
• Product Code: HMX
• UDI-Device Identifier: 00380654200200
• UDI-Public: 00380654200200
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/09/2024

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: 4200200001
• Device Lot Number: 166E6F
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 11/10/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Sex: Unknown