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

Catalog Number	8065441620
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that metal particles were appeared at the wound during cataract surgery while using ophthalmic cannula.Procedure was completed on the same day.Additional information received indicating that the metal particles were observed at the main wound was retained.There was swelling in the wounds.The particles were not able to see in post operation due to edema.The patient was advised for a day magnetic resonance due to the material seems metallic.There was no intervention and hospitalization following the event.Ophthalmic knives were also used during procedure.
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
Unopened lid and body, cystitome and cannula (c&c) cannulas in tip protector cases with lids were received for the report of metal particles noted at the wound and swelling wound and corneal edema.Samples were visually inspected by selecting 13 samples randomly and all 13 samples were found to be conforming.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 returned unopened samples were found to be conforming, therefore metal particles noted at the wound and swelling wound and corneal edema as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.However since the actual complaint samples were not returned, a root cause cannot be determined for the complaint as described by the customer.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 for the soft tip during the manufacturing process 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19270218
• Report Number: 2523835-2024-00903
• Device Sequence Number: 7430017
• Product Code: HMX
• UDI-Device Identifier: 00380654416205
• UDI-Public: 00380654416205
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065441620
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CANNULA OPHTHALMIC.; CLEARCUT KNIVES.; CUSTOM-PAK PACK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female