MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADVANCED OPTICS IOL; INTRAOCULAR LENS

Model Number	AO60
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Loss of Vision (2139); Eye Pain (4467)
Date of Event	02/21/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that 4 days after implantation of an intraocular lens (iol) in the left eye (os), the patient presented complaining of vision loss and eye pain.Slit lamp examination identified a fibrin reaction with hypopyon.Based on the findings the surgeon concluded the cause as endophthalmitis.Two days later, the patient was evaluated by a retina specialist who noted the view of posterior segment was limited due to vitreous opacity.A vitreous tap was performed, and an injection of vancomycin and ceftazidime was administered.The patient's best corrected visual acuity (bcva) decreased to hand motion.In the implanting surgeon's opinion, the most likely cause of the event could not be determined.The patient¿s outcome is unknown, as they have not returned for follow-up and cannot be reached.The following medications were prescribed for use at home post-operatively: prednisolone 1%: 1 gtt qid x 2 weeks, then tid x 2 weeks (total duration: 1 month), ofloxacin 0.3%: 1 gtt qid x 7 days, ketorolac 0.5%: 1 gtt qid x 2 weeks, then tid x 2 weeks (total duration: 1 month).

• Brand Name: AKREOS ADVANCED OPTICS IOL
• 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 place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25551289
• Report Number: 0001313525-2026-00071
• Device Sequence Number: 20220663
• Product Code: HQL
• UDI-Device Identifier: 10757770502032
• UDI-Public: (01)10757770502032(17)280731(11)250807(10)1R21105
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: AO60
• Device Catalogue Number: AO60P1900
• Device Lot Number: 1R21105
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: AMVISC PLUS, VIS100 INJECTOR, ALCON BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male