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	8065751511
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction g.3: supplemental medical device report (smdr) # 01 is being filed to correct the g.3 date on the initial report, filed earlier.Incorrect date of 28-may-2024 is being corrected to 02-may-2024.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during a cataract surgery irrigation and aspiration tip head had a ridge.The patient experienced mild capsular tear.The surgery was completed on the same day with an alternative product.The current outcome of the patient unknown.This report is second of three patients from the initial reporter.
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 an ophthalmic irrigation/aspiration tip capsule tore while gentle polishing.Details of procedure and patient harm was not reported.Additional details has been requested and none received till date.
Event or Problem Description
A physician reported that during a cataract surgery irrigation and aspiration tip head had a ridge.The patient experienced mild capsular tear.The surgery was completed on the same day with an alternative product.The current outcome of the patient unknown.This report is second of three patients from the initial reporter.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report that the tip tore the capsule.The photo review confirms the plastic protrusion reported by the customer; however, whether the protrusion is outside of the manufacturing specification cannot be confirmed.No lot number was identified with this complaint; therefore, a device history record review, complaint history review, and non-conformance review could not be conducted.A sample was not received at the manufacturing site and no lot information is available; therefore, the root cause for the customer complaint issue cannot be determined.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.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: 19614262
• Report Number: 2523835-2024-01547
• Device Sequence Number: 12506078
• Product Code: KYG
• UDI-Device Identifier: 00380657515110
• UDI-Public: 00380657515110
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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 Catalogue Number: 8065751511
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 08/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 06/28/2024; 09/25/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown