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

Catalog Number ASKU

Device Problem Complete Blockage (1094)

Patient Problem Eye Injury (1845)

Event Date 11/06/2020

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.(b)(4).

Event Description

A customer reported that a patient experienced a flattening of the anterior chamber and corneal burn during a right eye cataract procedure.The customer reported that the tip got blocked at one point during the case and the blockage was cleared outside the eye, but other than that there was nothing unusual.An occlusion tone was heard.Sutures were required.The customer reported that at 1 week post-op visit the corneal wound seemed okay and further treatment is not likely.

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.A sample was not received at the manufacturing site.And no lot information was provided.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 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
• MDR Report Key: 10931435
• MDR Text Key: 219115083
• Report Number: 2523835-2020-00303
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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: 11/06/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Required Intervention