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

Catalog Number	8065752987
Medical Device Problem Code	Energy Spectrum Incorrect (1210)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A customer reported that the eye was getting flashed, green laser light coming through in the top corner.The surgery was completed after replacing the product with another one.The details of patient impact was not reported.
Additional Manufacturer Narrative
Additional information provided in sections h.6.And h.11.Service history was reviewed for the system.A service record relevant to the reported complaint was found.Service record (sr) was opened to address the reported event.At the time of this investigation the service record remains open.The complaint investigation is being pursued at this time using available information.Based on the information obtained, the root cause of the reported event is inconclusive.A non-conformance based review of the 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 serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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).
Event or Problem Description
Following further review during a retinal procedure the physician initiated use of the ophthalmic laser he was getting flashed.The surgeon could see the green laser light coming in through the top right corner of the eyepiece when he closed his left eye.The procedure to the patient was successfully completed with no harm but out of concern that physician's own eye may be damaged, he had an oct performed on the right eye and there was no damage to the right eye.
Additional Manufacturer Narrative
Following the submission of the initial and follow-up reports, it was discovered that operator's right eye was getting flashed.The fda patient codes were updated from e2403 to e2402.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: 19268164
• Report Number: 2028159-2024-00687
• Device Sequence Number: 18016165
• Product Code: HQF
• UDI-Device Identifier: 00380657529872
• UDI-Public: 00380657529872
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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: 17262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 08/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/30/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown