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

Catalog Number	8065751593
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Retinal Tear (2050)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.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 during a surgical procedure to repair a retinal detachment on the patients right eye the laser probe emission failed.Due to the emission failure the patient experienced a hole in the retina.The procedure was completed after replacing the laser probe.Additional information has been requested.Additional information was received indicating the event occurred during a vitrectomy procedure.After air substitution was performed the retina where the laser spot was performed tore and bleed.The patient will be monitored.
Additional Manufacturer Narrative
The illuminated flex curved laser probe was received and a visual assessment of the returned sample revealed no obvious non-conformities.The illuminated flex curved laser probe sample was connected to a calibrated system and was found to meet specifications.It should be noted that a laser output test is performed during manufacturing to verify that the laser beam outputs properly and within power specification.The illuminated flex curved laser probe 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 number was performed.The returned illuminated flex curved laser probe was evaluated and was found to meet specifications.Therefore, the root cause of laser failure 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).

• 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: 12593289
• Report Number: 2028159-2021-01159
• Device Sequence Number: 11877248
• Product Code: HQE
• UDI-Device Identifier: 00380657515936
• UDI-Public: 00380657515936
• 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): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 8065751593
• Device Lot Number: 13RKX9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male