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	Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Visual Impairment (2138)
Date of Event	04/27/2026
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 11 days after implantation of an intraocular lens (iol) in the right eye (od), the patient presented with clinical findings consistent with endophthalmitis.At that time, visual acuity had decreased from 20/200 to hand motion.The patient was referred the same day to a retina specialist, who documented 1-2 anterior chamber cells, <1mm hypopyon, fibrinoid membrane at pupil, posterior synechiae, and dense vitreous opacities.A vitreous tap was performed, and intravitreal vancomycin and ceftazidime was administered.The culture showed no growth.In the implanting surgeon's opinion, the most likely cause of the event could not be determined.The following medications were prescribed for use at home post-operatively: prednisolone 1%: 1 gtt qid x 2 weeks, then bid 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 bid x 2 weeks (total duration: 1 month) medications documented at retina visit on (b)(6) 2026: prednisolone acetate: 1% 1 gtt ketorolac 0.5%: 1 gtt tid ofloxacin 0.3%: 1 gtt qid cyclopentolate 1%: 1 gtt tid.

• 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 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25551740
• Report Number: 0001313525-2026-00082
• Device Sequence Number: 14836395
• Product Code: HQL
• UDI-Device Identifier: 10757770607911
• UDI-Public: (01)10757770607911(17)280930(11)251011(10)3R27153
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• 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: EE
• Device Catalogue Number: EEU2200
• Device Lot Number: 3R27153
• 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
• 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, B+L INJECTOR SYSTEM, ALCON BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female