MAUDE Adverse Event Report: Bausch + Lomb enVista Toric Intraocular Lens; Lens, Intraocular, Toric Optics

Model Number	ETE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypopyon (1913); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately five weeks after implantation of an intraocular lens (iol), the patient presented with fibrin and hypopyon in the anterior chamber.Visual acuity decreased to count fingers at 20 feet.Based on the clinical findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).A tap procedure was performed, and a corticosteroid injection was administered.Due to the severity of the inflammation, oral corticosteroid therapy was initiated.The patient's condition subsequently improved; however, vision remains significantly reduced.Additional information was requested but was not received.
Additional Manufacturer Narrative
The device remains implanted.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/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause could not be conclusively determined.

• Brand Name: enVista Toric Intraocular Lens
• Common Device Name: Lens, Intraocular, Toric Optics
• 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 pl blvd; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 50931606
• Report Number: 0001313525-2026-00151
• Device Sequence Number: 9508968
• Product Code: MJP
• UDI-Device Identifier: 10757770614063
• UDI-Public: (01)10757770614063(17)270630(11)240729(10)3Q20068
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: ETE
• Device Catalogue Number: ETEU300+240
• Device Lot Number: 3Q20068
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male