MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	EE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Macular Edema (1822); Blurred Vision (2137); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Photophobia (4801); Eye Irritation (4803)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that two days after implantation of an intraocular lens (iol) into the right eye, the patient complained of blurry vision, photophobia, pain, and eye redness/irritation.Slit lamp findings were corneal edema, diffuse d folds, 2-3+ cell/flare, and fibrin/opacity covering iol.The patient¿s best correct visual acuity (bcva) decreased from 20/50 to 20/150.The patient was re-educated on eye drop administration and compliance and closely monitored over next few weeks and did not show much improvement.Approximately one month after the onset of symptoms, a vitreous tap was performed, and injections of vancomycin, ceftazidime and dexamethasone were administered.The patient was prescribed oral steroids.The culture had no growth.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).In the surgeon's opinion, the most likely cause of the event is unclear, but favors tass, stating that the findings were inconsistent with infectious endophthalmitis vs.Robust inflammatory response with cystoid macular edema.Patient has persistent macular edema and corneal edema/descemet's folds.Medications prescribed for use at home post-operatively: prednisolone qid then q1h then switched to durezol.Ofloxacin qid for 1 week.Durezol qid to bid (currently).
Additional Manufacturer Narrative
Additional information: b5, g3, h2.
Event or Problem Description
Additional information was received indicating the patient is still requiring treatment.

• 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; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22331520
• Report Number: 0001313525-2025-00133
• Device Sequence Number: 8411082
• Product Code: HQL
• UDI-Device Identifier: 10757770607874
• UDI-Public: (01)10757770607874(17)270630(11)240703(10)3Q17806
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: EE
• Device Catalogue Number: EEU2000
• Device Lot Number: 3Q17806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALCON DUOVISC, B+L INJECTOR SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male