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

Catalog Number 8065751761

Device Problem Energy Output Problem (1431)

Patient Problems Corneal Edema (1791); Corneal Perforation (1792); Corneal Clouding/Hazing (1878); Eye Burn (2523); Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/22/2022

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 nurse reported that an ophthalmic phacoemulsification (phaco) handpiece exhibited no phaco power during a cataract surgery.The occlusion tone was heard.A corneal burn was noted in patient's eye.The phaco attempt was stopped.The handpiece was replaced and the surgery was completed successfully.A corneal gap, leakage and opacity were noted.The patient also experienced anterior chamber collapse and low intra-ocular pressure (iop).The corneal wound was sutured and viscoelastic was used to close the incision and bandage contact lenses (bcl) were applied.The patient was examined post-operatively, corneal edema, low iop and the corneal opacity were still noted.The patient would require additional post-operative visits.

Manufacturer Narrative

The phacoemulsification (phaco) handpiece (hp) was received, and a visual assessment of the returned sample revealed that the phaco handpiece was third party repaired.The cable strain reliefs (attached to the hp at one end and the console connector at the other) did not match the specified product design color or include the manufacturer logo on the connector strain relief.Functional testing was not performed on this phaco handpiece per company standard operating procedure (sop), which states, ¿no functional testing is required to be performed if the phaco handpiece is found to have been third party repaired.¿ connection to the dynamic test fixture (dtf) revealed the serial number programmed on the electrically erasable programmable read-only memory (eeprom) during manufacturing of the handpiece did not match the serial number on the handpiece shell.A third party repaired phaco handpiece is no longer a company¿s product.A phaco handpiece 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 root cause cannot be determined conclusively.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: CENTURION 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: 14209819
• MDR Text Key: 290083697
• Report Number: 2028159-2022-00567
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517619
• UDI-Public: 00380657517619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; PHACO TIP; UNSPECIFIED PHACO TIP
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male