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

Catalog Number	8065752987
Medical Device Problem Codes	Defective Component (2292); Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an ophthalmic laser had no laser firing and issue with headpiece which axel was broken.Details of procedure and patient harm was not reported.Additional details has been requested and none received till date.
Additional 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).
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.11.The company representative was able to confirm the issue.A quote to replace the laser indirect ophthalmoscope (lio) was provided to the customer but has not yet been accepted.There was no product returned for testing on this investigation.The root cause of the reported event is attributed to nonconforming lio.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 nonconforming laser indirect ophthalmoscope (lio).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
• Common Device Name: 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: 19228327
• Report Number: 2028159-2024-00642
• Device Sequence Number: 6882988
• Product Code: HQF
• UDI-Device Identifier: 00380657529872
• UDI-Public: 00380657529872
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752987
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown