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

Catalog Number	8065751113
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
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 during a combination of cataract and vitrectomy surgery surgeon felt resistance while inserting tip into cannula.The probe was stuck halfway and could not be fully inserted into the cannula.The surgery was completed on the same day and there was no patient harm.
Additional Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The product was not returned for investigation testing.A non-conformance-based review of the batch/lot/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 lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/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).
Additional Manufacturer Narrative
The sample was received for testing on this investigation.Initial visual assessment of the returned sample revealed no obvious nonconformity.The returned sample was connected to a calibrated system and was successfully recognized.A visual assessment under a microscope was performed and identified a clear foreign material was present on the sample.A sample of the foreign material was collected, then sent to the lab to be isolated and microscopically analyzed.The analysis of the clear material was found to best match adhesive.An internal investigation into the manufacturing process was conducted.Adhesive is used to bond the nitinol to the cannula and applied at the handpiece/cannula juncture.At no point during the manufacturing process is adhesive applied along the length of the cannula where a trocar may be inserted.Cannula outer diameter is measured on 100% of laser probes to ensure the diameter is within specification prior to release.Thus, based the results of this review of the manufacturing process, how or when the adhesive was introduced onto the cannula is unable to be determined.The root cause of the reported event is attributed to adhesive being present on the cannula.However, how or when the adhesive was introduced onto the cannula remains 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).
Additional Manufacturer Narrative
The probe was received for this investigation for testing.A visual assessment of the returned sample revealed no obvious nonconformity.The returned sample was connected to a calibrated system and was successfully recognized.A visual assessment under a microscope was performed and revealed excess adhesive 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: 14746849
• Report Number: 2028159-2022-00817
• Device Sequence Number: 5175369
• Product Code: HQE
• UDI-Device Identifier: 00380657511136
• UDI-Public: 00380657511136
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup,Followup
• Report Date (Section B): 07/12/2023

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: 09/30/2024
• Device Catalogue Number: 8065751113
• Device Lot Number: 14431Y
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 05/05/2023; 06/15/2023
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/23/2022; 05/30/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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