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

Model Number	EZ-24
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.As a lot number for the device was not provided, the associated device history record was not reviewed.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.
Event or Problem Description
It was reported that an iol was removed from the left eye and replaced with a backup of the same model and diopter.The reason for this lens exchange is unknown.The incision was enlarged.Additional information was requested and not received.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 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: 18659320
• Report Number: 0001313525-2024-70024
• Device Sequence Number: 15469872
• Product Code: MSS
• UDI-Device Identifier: 00757770529032
• UDI-Public: (01)00757770529032
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: EZ-24
• Device Catalogue Number: EZ-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC, LI61AO IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female