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

Catalog Number 8065750263

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

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 physician reported that a small fragment was detected in a patient's iris at the slit lamp review the day after a cataract procedure.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; however, the provided customer photo confirms the report of foreign material in the eyes, the source of the foreign material cannot be determined from the photo.A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The reported event is confirmed based on the photo attached to parent complaint.However, because the source of the foreign material cannot be determined from the photo, a sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was released to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint 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.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).

Manufacturer Narrative

Correction g.4: supplemental medical device report (smdr) # 02 is being filed to correct the g.4 date on the initial/supplemental report, filed earlier.Incorrect date of 12/19/2019 is being corrected to 01/07/2020.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

D.3.Product manufacturing site updated due to receipt of additional information.G.9.Manufacturer report number corrected and reported under 2523835-2020-00019.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received from the surgeon about the current state of the patient.It was informed that there were no consequences and the patient was discharged.

• 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: 9516768
• MDR Text Key: 177981360
• Report Number: 1644019-2019-00208
• 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,Followup,Followup,Followup
• Report Date: 02/04/2021

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 8065750263
• Device Lot Number: 293451M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 01/07/2020; 02/12/2020; 03/13/2020; 01/15/2021
• Supplement Dates FDA Received: 01/28/2020; 02/12/2020; 03/16/2020; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK; UNSPECIFIED CUSTOM PAK, BEL