MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM, ACCESSORY, EMBEDDED LASER; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751450
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
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 physician reported that an ophthalmic console exhibited footswitch issue which caused a pause in laser treatment.At each pedal stroke, the laser paused, and no impact was delivered.The machine voice indicated laser paused.Additional information received indicated that the laser postponed to further consultation.There was no report on patient health current condition.
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.This report does not meet criteria for reporting as a device malfunction as the reported product endocular laser was not considered as a suspect for this incident no further reports will be reported under mfg report num 2028159-2022-01598.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM, ACCESSORY, EMBEDDED LASER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 15787253
• Report Number: 2028159-2022-01598
• Device Sequence Number: 20183941
• Product Code: HQC
• UDI-Device Identifier: 00380657514502
• UDI-Public: 00380657514502
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101285
• 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): 03/13/2023

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 Catalogue Number: 8065751450
• Device Lot Number: 13K4HE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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 Age: 70 YR
• Patient Sex: Female