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

Catalog Number	8065149523
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that an ophthalmic cannula had no soft tip inside the package during preparation of cataract surgery.Procedure completed on the same day.No patient harm was reported.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation, however the attached customer photo confirms the reported issue of during preparation of cataract surgery it was noticed there was no soft tip inside package.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 attached photo from the customer confirms the missing soft tip on the cannula.The exact root cause for this complaint could not be determined, however; possible contributing factors related to the internal manufacturing process cannot be conclusively ruled out.An investigation was initiated to investigate the cause of the missing soft tip on the cannula.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).
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; however the photo provided by the customer confirms the reported issue of during preparation of cataract surgery it was noticed there was no soft tip inside package.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 photo provided by the customer confirms the missing soft tip on the cannula.The missing soft tip is a manufacturing issue related to the cannula assembly process.An investigation was initiated to investigate the cause of the missing soft tip on the cannula.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.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: 16476961
• Report Number: 2523835-2023-00095
• Device Sequence Number: 7458917
• Product Code: HMX
• UDI-Device Identifier: 00380651495234
• UDI-Public: 00380651495234
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 04/14/2023

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: 8065149523
• Device Lot Number: 145F9C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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