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

Model Number	ETN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporting facility, the device was discarded and not available for evaluation.The device history record (dhr) review did not find any non-conformities or anomalies related to this 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, the root cause of the event could not be conclusively determined.
Additional Manufacturer Narrative
Additional info: b5, g3, h2, h11.Based on additional information received this event no longer meets reportability requirements and is no longer deemed reportable.
Event or Problem Description
Additional information was received indicating the exchange occurred approximately three weeks after implantation of the initial iol.In the surgeon's opinion, the most likely cause of the event was that the patient could not neuro-adapt.
Additional Manufacturer Narrative
The device was discards and not 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 approximately six weeks after implantation of an intraocular lens (iol) into the eye, the lens was exchanged with a toric monofocal iol due to the patient experiencing unresolved glare/halo disturbances.Additional information was requested, but not received.

• 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: 21410752
• Report Number: 0001313525-2025-00015
• Device Sequence Number: 9345620
• Product Code: MFK
• UDI-Device Identifier: 10757770640161
• UDI-Public: (01)10757770640161(17)271031(11)241108(10)3Q30647
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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: ETNU125+145
• Device Lot Number: 3Q30647
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/28/2025; 03/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/05/2025; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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 Sex: Unknown