MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MXUE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.
Event or Problem Description
It was reported that 9 hours after implantation of an intraocular lens (iol) into the left eye, the patient presented with decreased visual acuity, increased eye pressure (pre-op 14 mmhg, post-op 50 mmhg), corneal edema, 4+ cell and corneal folds (limbus to limbus).Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).The patient was treated with predisolone 1%, diclofenac, polymxin b sulfate and an injection of moxifloxacin, irrigation/aspiration and they added enoxaparin to bss.In the surgeon¿s opinion, the most likely cause of the event is tass.Patient outcome is unknown.
Additional Manufacturer Narrative
Updated g3, h2, h6, h11.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.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21894628
• Report Number: 0001313525-2025-00080
• Device Sequence Number: 11645297
• Product Code: HQL
• UDI-Device Identifier: 10757770531292
• UDI-Public: (01)10757770531292(17)270430(11)240504(10)3Q11531
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: MXUE
• Device Catalogue Number: MXUE1950
• Device Lot Number: 3Q11531
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLIS R1, TOTALVISC, BLIS X1, ALCON BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female