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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.Microscopic examination found part of the delivery tip end slightly bent out.The delivery tip did not exhibit a split or crack.The plunger rod was advanced up to the body tip, it was inspected, and no damage was observed.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, 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 could not be conclusively determined.
Event or Problem Description
It was reported that during insertion of an intraocular lens (iol) into the left eye, the lens came through the side of the injector, allegedly caused by a crack in the injector.The initial iol was removed intraoperatively, and a backup lens was successfully implanted.Patient outcome is good.

• 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 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 20724479
• Report Number: 0001313525-2024-00171
• Device Sequence Number: 6583112
• Product Code: MSS
• UDI-Device Identifier: 00757770520022
• UDI-Public: (01)00757770520022(17)250522(10)H2414301
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2025
• Device Model Number: EZ-28V
• Device Lot Number: H2414301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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 IOL, HEALON
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Unknown