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

Catalog Number 8065750469

Device Problem Suction Failure (4039)

Patient Problem Visual Impairment (2138)

Event Date 01/08/2024

Event Type  Injury  

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 Description

A customer reported that during a cataract surgery on the seventy-five-year-old male patient, an ophthalmic handpiece did not exhibit aspiration function.The handpiece was replaced, lens fragments were manually removed, and sutured.The patient was hospitalized and had to be operated again after eighteen days from initial surgery.The patient was not completely healed, suffered severe reduction in visual acuity, and underwent treatment.This complaint is pertaining the one of four reports received from the initial reporter.

Manufacturer Narrative

Additional information provided in sections h.6.And h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no product returned on this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.A non-conformance based review of the 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.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was determined to not be relevant to this investigation.The complaint was a similar event for a different patient.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).

• Brand Name: CONSTELLATION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: 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: 18823601
• MDR Text Key: 336734059
• Report Number: 2028159-2024-00321
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: 00380657504695
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: 13L63F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/03/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VS
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male