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

Catalog Number 8065751050

Device Problems Break (1069); Energy Output Problem (1431); Device Handling Problem (3265)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

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 healthcare professional reported that ophthalmic systems exhibited laser indirect ophthalmoscope poor performance.Customer has unscrewed the light guide.Replace light guide and recalibrate.Patient and procedure details were not reported.No patient harm was reported.

Manufacturer Narrative

Additional information is provided in sections " b.5 and h.6.The manufacturer internal reference number is:(b)(4).

Event Description

Additional information was received and stated that device was stored incorrectly and cable broken.

Manufacturer Narrative

The company representative was able to replicate the reported event.The nonconforming fiber was replaced to address the issue.The system was tested and found to meet product specifications.In a follow up phone call with the customer revealed the cable damage was attributed to a ¿user error- due to the device being stored incorrectly.¿ specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.The root cause of the reported event is attributed to broken cable due to storage method.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 LIO, LASER INDIRECT OPHTHALMOSCOPE
• 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: 18570197
• MDR Text Key: 333557083
• Report Number: 2028159-2024-00140
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM