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

Catalog Number	8065752556
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
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 physician reported that an ophthalmic illumination laser probe did not enter the cannula during a surgery.The surgery was completed after replacing the laser probe with another one.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.However, the product was returned for evaluation.The manufacturing device history record (dhr) was reviewed.The dhr was completed and reviewed by qa to ensure that the product was manufactured in compliance with the device master record.Based on qa assessment, the product met specifications.A review for complaints reported against this lot/batch/serial number was performed.There were no similar complaints were reported for the product lot/batch/serial under investigation.The ophthalmic laser probe was received for evaluation.A visual assessment of the returned sample revealed a small metal piece on the nitinol.The root cause of the reported event is attributed to a small metal piece on the nitinol.However, as to how or when the nitinol became nonconforming 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).

• 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: 13084574
• Report Number: 2028159-2021-01527
• Device Sequence Number: 5734547
• Product Code: HQE
• UDI-Device Identifier: 00380657525560
• UDI-Public: 00380657525560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 08/31/2022
• Device Catalogue Number: 8065752556
• Device Lot Number: 13N2XX
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 12/24/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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