MAUDE Adverse Event Report: ALCON LABORATORIES, INC. OZIL INFINIT HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 8065750469

Device Problem Disconnection (1171)

Patient Problem Capsular Bag Tear (2639)

Event Date 07/28/2022

Event Type  Injury  

Event Description

Patient was undergoing a phacoemulsification with intraocular lens implant for left eye cataract removal.During a critical point in the procedure the tubing disconnected from the infiniti handset and a sudden shallowing of the anterior chamber occurred.Once the equipment was inspected and tested to be working again the surgeon noted a posterior capsule rupture.An anterior vitrectomy was then preformed.The ophthalmology team then requested that the infiniti (older handpieces) be removed from use.The or was able to work with the vendor and obtain loaners until newer handpieces can be purchased.Manufacturer response for phaco handpiece, ozil infiniti handpiece (per site reporter).They have been made aware and they have provided the hospital with 5 loaners until new handpieces can be obtained.

Event Description

Patient was undergoing a phacoemulsification with intraocular lens implant for left eye cataract removal.During a critical point in the procedure the tubing disconnected from the infiniti handset and a sudden shallowing of the anterior chamber occurred.Once the equipment was inspected and tested to be working again the surgeon noted a posterior capsule rupture.An anterior vitrectomy was then preformed.The ophthalmology team then requested that the infiniti (older handpieces) be removed from use.The or was able to work with the vendor and obtain loaners until newer handpieces can be purchased.Manufacturer response for phaco handpiece, ozil infinit handpiece (per site reporter).They have been made aware and they have provided the hospital with 5 loaners until new handpieces can be obtained.

Event Description

Patient was undergoing a phacoemulsification with intraocular lens implant for left eye cataract removal.During a critical point in the procedure the tubing disconnected from the infiniti handset and a sudden shallowing of the anterior chamber occurred.Once the equipment was inspected and tested to be working again the surgeon noted a posterior capsule rupture.An anterior vitrectomy was then preformed.The ophthalmology team then requested that the infiniti (older handpieces) be removed from use.The or was able to work with the vendor and obtain loaners until newer handpieces can be purchased.Manufacturer response for phaco handpiece, ozil infinit handpiece (per site reporter).They have been made aware and they have provided the hospital with 5 loaners until new handpieces can be obtained.

• Brand Name: OZIL INFINIT HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 15416987
• MDR Text Key: 299868695
• Report Number: 15416987
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022,08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065750469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27010 DA
• Patient Weight: 110 KG
• Patient Race: Black Or African American