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

Catalog Number ASKU

Device Problems Break (1069); Particulates (1451)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

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 customer reported a chunk of yellow hard particle came from the handpiece during a surgery and it was retained in the patient¿s eye.Additional information received indicated the particle came from the plastic wrench, used to attach the tip onto the phacoemulsification (phaco) handpiece, and it was over-turned until the plastic wrench cracked, as a result, the plastic wrench broke and small yellow particle ended up inside the tip.There was no report of any patient harm.The product was discarded.Additional information was requested.

Manufacturer Narrative

This event does not meet criteria as a reportable malfunction based on information received following submission of the initial report.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received from the surgeon who indicated he was not sure if the particle was retained in the patient¿s eye.

Event Description

Additional information received indicating that the patient continued to experience no issues, but there was still potential that the patient had the particle in the eye.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The report of foreign material in the eye is confirmed based on the provided photo to the complaint.However, because the source and composition of the foreign material cannot be determined from the photo and a sample was not received at the manufacturing site, the root cause for 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).

Manufacturer Narrative

Additional information is provided in h.10.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.A possible contributing factor of the yellow particles is that the particulates were attributed to the over tightening of the tip wrench.However, based upon the information obtained and the clinical review, the root cause cannot be conclusively determined 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: 12602523
• MDR Text Key: 276594461
• Report Number: 2523835-2021-00380
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• 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
• Treatment: INFINITI VISION SYSTEM, HANDPIECE