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

Model Number	EN
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Macular Edema (1822); Corneal Clouding/Hazing (1878); Toxic Anterior Segment Syndrome (TASS) (4469); Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the right eye (od), the patient presented with inflammation.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).The patient was treated with topical steroid/antibiotics/nsaids.Ten days after implantation the surgeon reported corneal haze, stating the patient was improving with visual acuity at last appointment of 20/50 and decrease in inflammation.The following day, visual acuity was measured at 20/30, and the surgeon reported the patient was well on way to recovery.A week and a half later, the surgeon reported the issue resolved and the patient is seeing 20/20 j1.In the surgeon's opinion, the most likely cause of the event was the lens.The following medications were prescribed for use at home post-operatively: pred/moxi/prolensa.A month after the last update was received from the surgeon, the consumer reported an additional finding of secondary macular edema, stating she was referred to a retina specialist and had injection(s) of avastin administered.Allegedly, vision is coming back a little after the injections.
Event or Problem Description
Additional information received from consumer indicated she is still having issues with her eye.Additional information was requested but not received.

• Brand Name: ENVISTA ENVY 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 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21903295
• Report Number: 0001313525-2025-00097
• Device Sequence Number: 18325043
• Product Code: MFK
• UDI-Device Identifier: 10757770637284
• UDI-Public: (01)10757770637284(17)271231(11)250124(10)3R01610
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: ENU2150
• Device Lot Number: 3R01610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: J&J PLATINUM ONE INSERTER, VISCOAT OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female