MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ETN
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Corneal Ulcer (1796)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporting facility, the device was discarded and is not available to be returned for evaluation.A review of the device history record (dhr), did not find any anomalies or nonconformities related to the reported event.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information provided, a root cause could not be conclusively determined.
Event or Problem Description
It was reported approximately six weeks after implantation of a toric intraocular lens (iol) in the right eye (od), a lens exchange was performed using a lens of the same model, different diopter.In the surgeon¿s opinion, the most likely cause of the event was due to an iol rotation and that a different model iol may work better for the patient.Patient is currently being treated for corneal ulcer.
Additional Manufacturer Narrative
The device was discarded and not returned for evaluation.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

• Brand Name: ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21414324
• Report Number: 0001313525-2025-00016
• Device Sequence Number: 9345212
• Product Code: MFK
• UDI-Device Identifier: 10757770640161
• UDI-Public: (01)10757770640161(17)270831(11)240910(10)3Q23647
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 01/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: ETN
• Device Catalogue Number: ETNU300+210
• Device Lot Number: 3Q23647
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female