MAUDE Adverse Event Report: Bausch + Lomb enVista Envy hydrophobic acrylic intraocular lens; Lens, multifocal intraocular

Model Number	EN
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Hypopyon (1913); Intraocular Pressure Increased (1937); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.
Event or Problem Description
It was reported that 1 day after implantation of an intraocular lens (iol) into the left eye (os), the patient presented with 3+ cells, fibrin, and hypopyon.Patient's best corrected distance visual acuity (bcdva) decreased from 20/20-1 to 20/60-1.Based on the findings, the surgeon concluded the cause as toxic anterior segment syndrome (tass) and increased steroid drops.At the patient's 1-month post-op visit, inflammation had resolved with uncorrected distance visual acuity (ucdva) of 20/20 and uncorrected near visual acuity (ucnva) of j1.Due to findings of vitreous debris/veil, the patient was referred to retina for an evaluation.Approximately one week later, a pars plana vitrectomy (ppv) was performed due to residual vitreous debris.On week after ppv, the vitreous was found to be clear.In the surgeon's opinion, the most likely cause of the event is the iol.Patient outcome is good.Surgeon will continue to monitor intraocular pressure.Medications prescribed for use at home post-operatively: pred acetate 1% 1 gtt hourly.Cosopt 1 gtt bid (added 21-mar-2025).Brimonidine 0.2% 1gtt bid (added 22-mar-2025).

• 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 ; +1(727)724-6600
• MDR Report Key: 22287524
• Report Number: 0001313525-2025-00130
• Device Sequence Number: 8458483
• Product Code: MFK
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: ENU1150
• Device Lot Number: 3Q29020
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male