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

Model Number	EN
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 4 weeks after implantation of an intraocular lens (iol) into the right eye (od), the patient complained of poor vision and stated he felt like his right eye was seeing underwater.Upon evaluation the surgeon noticed a slight irregularity or possible optical aberration in the central optic of the lens described as a slight dent that in his opinion was impacting the patient's vision.The lens was exchanged, approximately two weeks later with a different model iol, and patient outcome post exchange is reported as good.
Additional Manufacturer Narrative
The device was returned and evaluated.Only a piece of the optic and haptic was received.Microscopic examination found the lens cut across the optic and haptics.A tear and slight scratches were observed on the optic.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.It is noteworthy to mention the inserter and viscoelastic used were not identified, so we are unable to determine if a validated inserter and viscoelastic were used.Based on the available information, the root cause could not be conclusively determined.

• Brand Name: ENVISTA ENVY 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 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22048826
• Report Number: 0001313525-2025-00111
• Device Sequence Number: 13016181
• Product Code: MFK
• UDI-Device Identifier: 10757770637215
• UDI-Public: (01)10757770637215(17)270831(11)240911(10)3Q24765
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: EN
• Device Catalogue Number: ENU1750
• Device Lot Number: 3Q24765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES96594
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male