MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065751512
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
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 physician reported that before cataract surgery, an ophthalmic irrigation and aspiration tip was found to be twisted.The surgery was performed and completed after replacing the tip with another one.There was no contact with the patient.
Additional Manufacturer Narrative
Additional information was provided in sections d.4, d.9, h.3 h.6 and h.11.One opened polymer irrigation and aspiration tip was returned for the reported issue of twisted joint.The returned sample was visually inspected and was found to be nonconforming with damaged threads, cross threading observed.Foreign material white and orange in color was also observed in the back hole and on flat area near back hole.The sample was sent for particle analysis.The elements for the orange material contains mixed minerals, salts, and rust.The elements for the white material contains mixed salts and trace amounts of metals.The exact identities of the orange material and white material are unknown.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 irrigation and aspiration tip became damaged cannot be determined from this evaluation; therefore, a root cause cannot be determined for the complaint as described by the customer.Most likely root cause is handling of the product when placing on the handpiece as the threads were found to be cross threaded.The particle analysis found the foreign material to contain mixed minerals, salts, and rust for the orange material and mixed salts and trace amounts of metal for the white material.The exact identities of the orange and white material are unknown.Salts are not materials used in the manufacturing process.How and when these materials got in the product cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.Possible root cause for the foreign material is from the handpiece when trying to threaded the tip onto the handpiece.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.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: DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
• 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: 19458267
• Report Number: 2523835-2024-01196
• Device Sequence Number: 6735332
• Product Code: KYG
• UDI-Device Identifier: 00380657515127
• UDI-Public: (01)00380657515127(17)250930(11)231012(10)168UW1(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): 01/09/2025

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: 09/30/2025
• Device Catalogue Number: 8065751512
• Device Lot Number: 168UW1
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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