MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION

Catalog Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Abrasion (1789); Eye Pain (4467)

Event Date 03/01/2021

Event Type  Injury  

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 Description

A customer reported some pieces of foreign materials retained in eye that was discovered post-surgery with no report of any patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report; therefore, the condition of the product could not be verified.Multiple photos are attached to the parent file and have been reviewed by the investigation site.Photos include non-medical devices, hand drawings, medical paperwork, and diagrams of eye anatomy, all to support the reported events from the customer.The provided photos do not show a medical device and, therefore, do not confirm any events directly associated with the reported medical device.No lot number was identified with this complaint; therefore, a device history record 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 cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.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: PHACO TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• 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: 17438441
• MDR Text Key: 320200506
• Report Number: 2523835-2023-00409
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other