MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER PUREPOINT LIO, LASER INDIRECT OPHTHALMOSCOPE; LASER, OPHTHALMIC

Catalog Number 8065751050

Device Problem Device Inoperable (1663)

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.(b)(4).

Event Description

A customer reported that the indirect laser was not working and the touchscreen did not work with the infusion button.

Manufacturer Narrative

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

Event Description

A customer reported that the indirect laser was not working and the touchscreen did not work with the infusion button.Additional information was received indicating that this event occurred prior to a surgical procedure.There was no patient involvement.

Manufacturer Narrative

The system and laser indirect ophthalmoscope (lio) were examined and the reported event was replicated, as the laser footswitch was found non-conforming.The company representative advised the customer to order a new footswitch and have it installed.The touchscreen was also recalibrated on the laser as a preventive measure.However, the system and lio were not tested.Therefore, the root cause cannot effectively be determined conclusively.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on june 21, 2012.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: PUREPOINT LIO, LASER INDIRECT OPHTHALMOSCOPE
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7448608
• MDR Text Key: 106302684
• Report Number: 2028159-2018-00814
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751050
• Device Lot Number: ASKU
• Other Device ID Number: 380657510504
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other