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

Model Number EZ-24

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

Patient Problems Capsular Bag Tear (2639); Insufficient Information (4580)

Event Date 11/01/2023

Event Type  Injury  

Event Description

It was reported that due to a capsule tear in the right eye, the intraocular lens (iol) was replaced with a different model and diopter iol.Additional information was requested, but not received.

Manufacturer Narrative

Although requested, the device has not been received for evaluation and additional information regarding the event was not provided.The investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Manufacturer Narrative

The intraocular lens (iol) involved in the event was returned for evaluation.Microscopic examination was performed and found the lens stuck in another manufacturer''s cartridge.The ez-24 inserter that was originally reported is not validated for use with the reported iol.Therefore, the lens was not advanced to be implanted in the eye and it can be concluded that the injector involved was not a b+l injector.Based on the product evaluation of the iol, it was determined the device causality is unrelated and therefore, this event no longer meets reportability requirements and is no longer deemed reportable.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 18655834
• MDR Text Key: 334721867
• Report Number: 0001313525-2024-70012
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: EZ-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMVISC, ENVISTA IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female