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	8065751510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2024
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 surgical tip attached to a hand piece was torn off from its root.It was also reported that, the screw part of the root kept attached to the hand piece and an upper part from there was torn off.The surgery was completed on the same day after replacing the product with another one.The patient impact was not reported.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened and broken polymer irrigation/aspiration (i/a) tip, in a bag was returned for the reported issue of a torn irrigation/aspiration (i/a) tip.The returned sample was visually inspected and was found to be non-conforming with threads observed to be broken off with the cannula and the hub ribs remaining.The hub ribs are twisted in a spiraling motion.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.A photo attached to the parent complaint was reviewed by the investigation site.Image shows a handpiece with appears to be the thread end of a the irrigation/aspiration (i/a) tip.The reported issue was confirmed from the photo.The returned non-conforming sample was received opened.How and when the irrigation/aspiration (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 irrigation/aspiration (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: 19999926
• Report Number: 2523835-2024-01981
• Device Sequence Number: 17362682
• Product Code: KYG
• UDI-Device Identifier: 00380657515103
• UDI-Public: (01)00380657515103(17)250731(11)230831(10)164U19(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,Followup
• Report Date (Section B): 11/18/2024

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: 07/31/2025
• Device Catalogue Number: 8065751510
• Device Lot Number: 164U19
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 10/22/2024
• Initial Report FDA Received Date: 08/19/2024
• Supplement Report FDA Received Date: 10/11/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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