MAUDE Adverse Event Report: BAUSCH + LOMB EASY-LOAD LENS DELIVERY SYSTEM; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number EZ-28V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vitrectomy (2643)

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation.Functional testing was performed and the injector delivered the iol without any issues.A review of the device history record (dhr), did not find any non-conformities or anomalies related to this event.Additional information was requested, but not received.Based on the available information, the cause of vitrectomy is unclear and can not be traced to the device.

Event Description

It was reported that due to unknown reasons, the lens was removed and replaced intra-operatively and a vitrectomy was performed.There were no sutures, and incision was not enlarged.Additional information has been requested, but not received.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 park place; clearwater, FL 33759
• MDR Report Key: 9513696
• MDR Text Key: 182775267
• Report Number: 0001313525-2019-00220
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,11/26/2019

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 Expiration Date: 05/20/2020
• Device Model Number: EZ-28V
• Device Lot Number: H953501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other