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

Model Number	EZ-28V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, additional information regarding the event was not provided and the inserter was not returned for investigation.The lot number of the device was not provided; therefore, a device history record (dhr) review could not be performed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the information provided, a root cause could not be conclusively determined.
Event or Problem Description
Reportedly, iol was removed after insertion due to damaged haptic.Incision was enlarged to remove the iol, and a suture was required to close the wound.Patient was left aphakic.Per the surgeon the lens was not able to stick to the eye.Additional information was requested but not received.
Additional Manufacturer Narrative
Additional information: based on the additional information received, the device causality was assessed unrelated to the event, and therefore, this event no longer meets reportability requirements and no longer deemed reportable.
Event or Problem Description
Additional information was received indicating the event was patient-related.Based on additional information received, this event no longer meets reportability requirements and is no longer deemed reportable.

• 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: 18741694
• Report Number: 0001313525-2024-70049
• Device Sequence Number: 7233830
• Product Code: MSS
• UDI-Device Identifier: 00757770520022
• UDI-Public: (01)00757770520022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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-28V
• Device Catalogue Number: EZ-28V
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/23/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOFPORT SQUARE EDGE IOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown