MAUDE Adverse Event Report: Bausch + Lomb eVista 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	Corneal Edema (1791); Hypopyon (1913); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Posterior Capsule Opacification (4807)
Date of Event	02/20/2025
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 1-day post-implantation of an intraocular lens (iol) into the right eye (od), the patient presented with layered hypopyon, fibrin in ac, and minimal corneal edema.Intravitreal injections of ceftazidime and vancomycin were administered, and a culture was taken for suspected endophthalmitis.Results of the culture were negative.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Patient outcome is good.The following medications were prescribed for use at home postoperatively: compound prednisolone 1%, moxifloxacin 0.5%, nepafenac 0.1% 1 gtt qid x 1 week tapering weekly for 4 weeks.Prednisolone 1% 1gtt qid alternating with combo drop.Taper schedule.

• Brand Name: eVista 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 ; +1(727)724-6600
• MDR Report Key: 21864999
• Report Number: 0001313525-2025-00060
• Device Sequence Number: 4696010
• Product Code: MFK
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/17/2026
• 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: B+L INJECTOR SYSTEM, ALCON DUOVISC, ALCON BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male