MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INFINITI VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number 8065790022

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 pharmacist assistant reported that the tip was bent.There was no information about completion of surgery.The procedure type was unknown.There was no information about patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report.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 attached photo confirms the report, however because a sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause is unknown, therefore specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance exhibited on the returned opened sample, is removed from the lot and scrapped.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 further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM, HANDPIECE 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: 18638306
• MDR Text Key: 334496504
• Report Number: 2523835-2024-00080
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K021566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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
• Device Operator: Other
• Device Catalogue Number: 8065790022
• Device Lot Number: 152ADE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1