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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the insertion of an intraocular lens (iol) the distal tip of the inserter split, causing the lens to exit laterally.A backup lens was successfully implanted and there was no patient injury.This event involved two inserters.This is report 2 of 2, report 1 of 2 is referenced in report 0001313525-2024-70063.
Additional Manufacturer Narrative
The investigation of this event is still ongoing.A follow-up report will be provided upon conclusion of the investigation.
Additional Manufacturer Narrative
The device involved in this event was discarded.One unopened device from the same lot was returned and evaluated.Microscopic examination was performed and a cracked/split delivery tip was observed.Based on the available information, device manufacturing may have contributed to the event.Corrective measures have been implemented to mitigate future similar occurrences.Bausch & lomb will continue to monitor similar events to determine if additional actions are required.
Event or Problem Description
This is report 2 of 3.Reference 0001313525-2024-00077 and 0001313525-2024-70063.

• 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: 18851857
• Report Number: 0001313525-2024-70064
• Device Sequence Number: 15275042
• Product Code: MSS
• UDI-Device Identifier: 00757770520022
• UDI-Public: (01)00757770520022(17)241113(10)H2331401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 11/13/2024
• Device Model Number: EZ-28V
• Device Catalogue Number: EZ-28V
• Device Lot Number: H2331401
• 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: 03/06/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• 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 AO INTRAOCULAR LENS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown