MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number	8065752555
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
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 nurse reported that the ophthalmic laser probe was not delivering laser energy and that no laser spot was visible before the cataract and vitrectomy combination surgery.The surgery was completed and there was no patient impact was reported.
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3 , d.4 ,h.6 and h.11.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.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.Device was received at the manufacturing site.A visual assessment of the returned samples revealed no obvious nonconformities.The first returned sample was connected to a calibrated system and was successfully recognized.A visual assessment of the returned sample revealed a non-conforming optical fiber at the subminiature version a (sma) connector.Functional testing was performed and confirmed the issue.The second returned sample was connected to a calibrated system, and was successfully recognized.Sample testing was performed and revealed a burnt subminiature version a (sma) connector.Refer to the attached investigation log and photo(s).Sample evaluation at manufacturing revealed the sample had a non-conforming optical fiber at sma connector and a burnt sma connector.Based on the results of this investigation, the reported event was confirmed.The root causes of the reported event is attributed to a non-conforming optical fiber at sma connector and a burnt sma connector.This complaint has been reviewed and based on a low occurrence rate, it is determined that no further actions are necessary 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: LASER PROBES
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• 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: 20133183
• Report Number: 2028159-2024-01306
• Device Sequence Number: 7287470
• Product Code: HQE
• UDI-Device Identifier: 00380657525553
• UDI-Public: (01)00380657525553(17)251231(11)240117(10)16FA9V
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 8065752555
• Device Lot Number: 16FA9V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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
• Patient Sex: Unknown