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

Model Number	EN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Vitreous Floaters (1866); Hypopyon (1913); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Posterior Capsule Opacification (4807)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 1 day after implantation of an intraocular lens (iol) into the right eye (od), the patient presented at the postoperative appointment with the chief complaint of an inability to see.Slit lamp examination identified 4+ corneal edema.Intravitreal injections of vancomycin and ceftazidime were administered the same day.Culture and sensitivity testing revealed no organisms, with moderate white blood cells present.The retina specialist, who managed the patient postoperatively, documented a differential diagnosis of toxic anterior segment syndrome (tass) versus endophthalmitis.At the 1-week postoperative visit, slit lamp findings showed improvement, fibrin membrane and hypopyon were no longer present.At the 2-week postoperative visit, the patient reported intermittent blurry vision.Clinical examination continued to show improvement, including decreased vitreous debris and a clear cornea.At approximately seven weeks postoperative, the patient demonstrated continued clinical improvement, the vitreous was noted to be clear without hemorrhage, cells, or pigment.The patient was diagnosed with posterior capsule opacification (pco).At 4.5 months postoperative, the patient had tapered off all topical medication and reported constant blurry vision and disturbance from by vitreous debris.Examination showed a quiet anterior segment, a centered pciol with posterior capsular opacification, and vitreous debris.The macula demonstrated pigment clumping and drusen.Optical coherence tomography (oct) findings were consistent with dry age-related macular degeneration.The patient was referred back to the implanting surgeon to schedule a yag laser capsulotomy, with reassessment planned to follow the procedure.Medications prescribed for use at home post-operatively: pred-moxi-brom (combo drop) 1 gtt qid bid qd durezol 0.05% qid moxifloxacin 400 mg qd x 7 days vigamox 0.5% qid bid cyclogyl 1% tid (d/c (b)(6) 2025) preservative free drops qid tid qd qod.
Additional Manufacturer Narrative
The device remains implanted.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.Based on the available information, the root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.

• 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 n park pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 24804434
• Report Number: 0001313525-2026-00027
• Device Sequence Number: 9943771
• Product Code: MFK
• UDI-Device Identifier: 10757770637079
• UDI-Public: (01)10757770637079(17)270831(11)240919(10)3Q25720
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: ENU1000
• Device Lot Number: 3Q25720
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC, B+L INJECTOR SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male