MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number 8065751593

Device Problem Difficult to Insert (1316)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.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 physician reported that an ophthalmic laser probe exhibited difficulty inserting into a trocar during a combination cataract and vitrectomy surgery.The procedure was able to be completed while using the unsatisfactory laser probe.There was no harm to the patient.

Manufacturer Narrative

The 25 gauge illuminated flex curved laser probe was received and a visual assessment of the returned sample showed no obvious non-conformities.Further evaluation found that the sample did not fit into a trocar.The complaint was confirmed.Based on qa assessment, the product met specifications at the time of release.A review of complaints for the last 12 months did not indicate any additional related reports for the reported lot number.The root cause of the reported event can be attributed to the non-conforming probe tip.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: LASER PROBES
• Type of Device: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10721652
• MDR Text Key: 214122566
• Report Number: 2028159-2020-00864
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• PMA/PMN Number: K946135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 8065751593
• Device Lot Number: 13L03V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION,TABLETOP