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

Catalog Number	8065750991
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 laser probe does not fit through the cannula ports.Procedure details and patient impact have not been provided.Additional information received clarified that event occurred during posterior vitrectomy surgery.The surgery was completed by disconnecting the laser probe and connecting another laser probe.There was no harm to the patient.
Additional Manufacturer Narrative
No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The 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).
Additional Manufacturer Narrative
The laser probe was received for evaluation.A visual assessment of the returned sample revealed no obvious non-conformities.Further evaluation using a microscope, the sample was found to have an unknown debris on the tip.However, how or when this nonconformity occurred remains inconclusive.It should be noted that the laser probes are visually inspected during manufacturing, to verify the tips are conforming.Based on the information available, the customer reported event cannot be confirmed.The 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: 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: 11795768
• Report Number: 2028159-2021-00480
• Device Sequence Number: 3962374
• Product Code: HQE
• UDI-Device Identifier: 00380657509911
• UDI-Public: 00380657509911
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2022

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: 04/30/2023
• Device Catalogue Number: 8065750991
• Device Lot Number: 13L9JJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 01/21/2022
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 08/14/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown