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

Catalog Number 8065750597

Device Problem No Display/Image (1183)

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

Event Date 07/14/2022

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 an ophthalmic console exhibited with no clear view.Procedure details and patient impact have not been provided.Additional information has been requested.Additional information received indicating issue was resolved with restarting the laser.The surgery was completed with no patient harm.

Manufacturer Narrative

The company representative confirmed and replicated the reported event.To address the issue the flex cable and liquid crystal display (lcd) card in the printed circuit board (pcb) were both replaced.The system was tested and found to meet product specifications.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause of the reported event is attributed to internal component failure.The specific component, between the lcd card and flex cable, that contributed to the reported event remains inconclusive.Without samples, the component level root cause cannot be determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15216514
• MDR Text Key: 297775578
• Report Number: 2028159-2022-01161
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00380657505975
• UDI-Public: 00380657505975
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: 8065750597
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1