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	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Though requested of the reporter, the device has not been returned for evaluation.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that after loading the intraocular lens(iol) into the injector, the iol was protruding out the side of the injector.The protrusion was noticed during preparation for use, and there was no contact or injury to the patient.
Additional Manufacturer Narrative
The device was returned and evaluated.Microscopic examination was performed and found two tears on the side of the cartridge body.One tear exhibited the lens protruding through the side of the cartridge body and the other tear was in close proximity to the first tear.No damage was observed in the cartridge tip, the plunger rod was up against the back of the optic, and little to no viscoelastic was visible in the loading deck or cartridge.A review of the device history record (dhr), did not find any anomalies or nonconformities related to the reported event.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have contributed to the event.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; 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: 16458995
• Report Number: 0001313525-2023-00034
• Device Sequence Number: 12374364
• Product Code: MSS
• UDI-Device Identifier: 00757770520022
• UDI-Public: (01)00757770520022(17)231031(10)H270102
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 10/31/2023
• Device Model Number: EZ-28V
• Device Catalogue Number: EZ-28V
• Device Lot Number: H270102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/01/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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 LI61AO IOL.
• Patient Age: 75 YR
• Patient Sex: Male