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 Visual Impairment (2138)

Event Date 01/24/2024

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 335780048
• Report Number: 0001313525-2024-70049
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2024
• 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: SOFPORT SQUARE EDGE IOL.
• Patient Outcome(s): Required Intervention