MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC

Catalog Number 8065750597

Device Problem Break (1069)

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

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 the laser "does not paint", port 2 was red, and the foot pedal was damaged.

Manufacturer Narrative

The system was examined and the reported event was replicated.The company representative cleaned/lubricated the port selector and diode assembly of laser and then replaced the footswitch to resolve the issue.The system was tested and found to meet product specifications.The system was manufactured on may 19, 2010.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported ¿laser issue¿ can be attributed to an ¿external/coincidental event, unrelated to product.¿ the root cause of ¿footswitch issue¿ can be attributed to ¿internal-component-wear/reliability¿ since the footswitch was found non-conforming.The manufacturer internal reference number is: (b)(4).

• Brand Name: PUREPOINT LASER
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9814431
• MDR Text Key: 185612441
• Report Number: 2028159-2020-00230
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• PMA/PMN Number: K062624
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2020
• Device Catalogue Number: 8065750597
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1