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

Model Number	ETN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Eye Pain (4467)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was report that 1-day after implantation of an intraocular lens (iol) into the eye, the patient presented with high intraocular pressure (iop) and had pain.An anterior chamber tap was performed, the pressure came down the following day, and the patient has not reported any symptoms post-treatment.Additional information was requested but not received.This is lens #2 of 2 for this patient.Ref: (b)(4).
Additional Manufacturer Narrative
The device remains implanted.As a serial number for the device was not provided, the associated device history record was not reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.Bausch + lomb will continue to monitor for similar occurrences.

• Brand Name: ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS
• 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: 23707568
• Report Number: 0001313525-2025-00215
• Device Sequence Number: 16114662
• Product Code: MFK
• UDI-Device Identifier: 10757770641472
• UDI-Public: (01)10757770641472
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: ETNU200+225
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown