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

Model Number EZ-28V

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The investigation of this event is still ongoing.A follow-up report will be provided upon conclusion of the investigation.

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 Description

This is report 2 of 3.Reference 0001313525-2024-00077 and 0001313525-2024-70063.

• 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: 18851857
• MDR Text Key: 337085820
• Report Number: 0001313525-2024-70064
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770520022
• UDI-Public: (01)00757770520022(17)241113(10)H2331401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• 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 AO INTRAOCULAR LENS
• Patient Outcome(s): Other