MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED ENVISTA ENVY LENS LEFT EYE; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ENU2100
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I had bausch and lomb envista envy lens implants on (b)(6) 2025.Both eyes had high pressure following surgery.The second surgery eye (right) was more significant than the first.It resulted in extremely high eye pressure, distorted vision, having to be placed on another eye drop to bring down eye pressure (two pressure reducing drops initially).Ref report: mw5168959.

• Brand Name: ENVISTA ENVY LENS LEFT EYE
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 21832611
• Report Number: MW5168960
• Device Sequence Number: 9373588
• Product Code: MFK
• UDI-Device Identifier: 10757770637277
• UDI-Public: (01)10757770637277(17)270930(11)241015(10)3Q31607
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/09/2025

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?: Yes
• Device Model Number: ENU2100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander