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

Catalog Number 8065750597

Device Problem Protective Measures Problem (3015)

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

Event Date 09/18/2018

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.(b)(4).

Event Description

A customer reported that during a photocoagulation procedure, the laser disabled after two fires.The system was rebooted to complete the case.There was no patient harm.

Manufacturer Narrative

The laser footswitch was received and a visual assessment of the returned sample showed no obvious nonconformities.The footswitch was installed into a calibrated system for functional testing.The reported event could not be replicated.No system messages (sm) were displayed and laser was not disabled.The footswitch was found to be functioning as intended.The root cause of the reported event can be attributed to a non-conforming footswitch.However, how or when it became nonconforming could not be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company service representative examined the system and replicated the system message (sm) - [laser controller dr filter error.Laser functions will be disabled].The footswitch was replaced to resolve the issue.The system was then tested and met all product specifications.The system was manufactured on june 11, 2009.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a non-conforming footswitch.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: 7968884
• MDR Text Key: 123950375
• Report Number: 2028159-2018-02159
• 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,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1