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

Catalog Number 8065750597

Device Problem Failure to Deliver Energy (1211)

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

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

An non health care professional reported that ophthalmic laser did not burn well.Procedure and patient details were an unknown.There was no patient harm reported.

Manufacturer Narrative

Additional information is provided in sections h.6 and h.10.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.A potentially relevant complaint was found and reviewed as part of this investigation.The customer reported that the laser sometimes does not work but the root cause was determined to be inconclusive ¿ no problem found.Service history was reviewed for the system.A service record relevant to the reported complaint was found and reviewed to address the reported event.Manufacturer representative performed an on-site assessment and was unable to confirm or replicate the reported event.As a preventative measure, assy,fiber,50mcrn of the system was replaced then found the system to meet manufacturer specifications per service test procedure (stp).Based on the information available, the customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.The root cause of the reported event is inconclusive.Therefore, no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.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: 17786750
• MDR Text Key: 323894532
• Report Number: 2028159-2023-01271
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1