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

Catalog Number	8065149529
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
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).
Event or Problem Description
A healthcare professional reported that during surgery, the ophthalmic soft tip came off as the tip was introduced into the vitreous cavity.Procedure details and patient impact have not been provided.Additional information has been requested, none received till date.
Event or Problem Description
Additional information received indicated that the issue occurred during retinal surgery.The surgery was completed without any problem after removing the tip.There was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in section a3.A.B.3, b.5, d.4, h.4, h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in sections h.6 and h.11.A sample was not received at the investigation site for evaluation for the report of tip came off inside vitreous cavity; therefore, the condition of the product could not be verified.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 photos and videos attached to the parent file were reviewed by the manufacturing site.Photo 1 shows a pak label, the reported product and lot information is confirmed.Photo 2 shows a cannula in an opened pack.Video 1 shows a cannula being removed from the eye with no soft tip attached.Video 2 shows the retrieval process of the soft tip from the eye.The reported issue is confirmed from the photo/video review.The video review confirms the reported issue of tip came off inside vitreous cavity; however, because a sample was not received and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.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: 21353086
• Report Number: 2523835-2025-00121
• Device Sequence Number: 9003213
• Product Code: HMX
• UDI-Device Identifier: 00380651495296
• UDI-Public: (01)00380651495296(17)260731(11)230804(10)161E1U
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 8065149529
• Device Lot Number: 161E1U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/12/2025; 04/30/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/02/2025; 05/06/2025
• Date Device Manufactured: 08/04/2023
• 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: Male