MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065752144
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported that an ophthalmic surgical irrigation and aspiration tip was found bent before surgery.The surgery was completed on the same day with alternative product.Details of procedure and patient harm was not reported.Additional details has been requested and none received till date.
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
Additional information is provided in sections d.4, d.9, h.3, h.6 and h.11.One opened polymer i/a coaxial straight was returned for the reported issue of bent tip.The returned sample was visually inspected and was found to be nonconforming with the tip attached to the coaxial i/a handpiece observed to be bent where metal cannula comes out of over molded plastic.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 returned non-conforming sample was received opened.How and when the i/a tip became damaged cannot be determined from this evaluation; therefore 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 i/a tips are 100% visually inspected prior to being released from the manufacturing facility.The manufacturer internal reference number is: (b)(4).

• Brand Name: INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: 18968329
• Report Number: 2523835-2024-00437
• Device Sequence Number: 6154842
• Product Code: KYG
• UDI-Device Identifier: 00380657521449
• UDI-Public: (01)00380657521449(17)250430(11)230525(10)15PRFY(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/09/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 8065752144
• Device Lot Number: 15PRFY
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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: Unknown