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

Catalog Number ASKU

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

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 that surgeon found a metal fragments in the eye of a patient during a cataract procedure.There is no patient harm.

Manufacturer Narrative

A sample was not received, at the manufacturing site for evaluation.For the report of there were metal fragments in the eye of the patient.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.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).

Event Description

The surgeon observed, metal flakes in the patient¿s eye at the end of a cataract procedure.The surgeon chose to leave them in the patient¿s eye.No further treatment was planned.No patient harm reported.

• 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
• MDR Report Key: 12202487
• MDR Text Key: 262647576
• Report Number: 2523835-2021-00258
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1