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

Catalog Number 8065750469

Device Problems Energy Output Problem (1431); Failure to Prime (1492)

Patient Problems Corneal Edema (1791); Retinal Tear (2050); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/23/2022

Event Type  Injury  

Event Description

A physician reported that during a surgery while using a ophthalmic handpiece ultrasound was too strong and the handpiece failed to pass test and error message was displayed in the system.There was a patient harm of capsular tear and corneal edema.Additional information has been requested.Additional information received clarified that the issue happened during combined phacoemulsification and vitrectomy surgery for vitreomacular traction syndrome.Patient had also experienced anterior capsular rupture and the issue occurred at the beginning of sculpt/ upon grooves creation in the nucleus or extraction of 1st quadrant during use of ultrasounds.Patient was given with mydriasert before surgery and duovisc, antibiotics at the end of the procedure.Secondary implantation of an artisan type implant planned ten days later.

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

Additional information received clarified that the corneal edema was completely resolved also the corneal sutures removed and a secondary implantation of an artisan type implant was done.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was received and a visual assessment of the returned sample revealed no visual nonconformity.The returned phaco handpiece was connected to a calibrated vision system.The phaco handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the phaco handpiece to meet product specifications.A phaco handpiece 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.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The 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: 15454407
• MDR Text Key: 300219005
• Report Number: 2028159-2022-01351
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: 00380657504695
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 11/09/2022
• Supplement Dates FDA Received: 10/17/2022; 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; TABLE TOP CR5
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 55 KG