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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/12/2024
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 customer reported that an ophthalmic tip was used to perform a surgery.The patient experienced tear in the capsule.The surgery was completed.Procedure details was not reported.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened curved polymer i/a tip in a wrench was returned for the reported issue of a capsule tear.The returned sample was visually inspected and was found to be conforming.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 to the parent complaint were reviewed by the investigation site.Image 1: the photo shows a label with same product and lot number as reported.Image 2 (in email): the photo shows a disposable i/a tip in a wrench in a bag with a note indicating that the i/a tip is suspected to have a rough or jagged surface.The reported issue could not be confirmed from the photo review.The returned sample was found to be visually conforming; therefore, a rough or jagged surface that caused a tear in capsule as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the tip was manufactured to specifications.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: 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: 20879392
• Report Number: 2523835-2024-02428
• Device Sequence Number: 15407203
• Product Code: KYG
• UDI-Device Identifier: 00380657515127
• UDI-Public: (01)00380657515127(17)260831(11)240919(10)172F8D(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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: 08/31/2026
• Device Catalogue Number: 8065751512
• Device Lot Number: 172F8D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 02/10/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/02/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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