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	Vitreous Floaters (1866); Hypopyon (1913); Intraocular Pressure Increased (1937); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Photophobia (4801); Retinal Hemorrhage (4809)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.
Event or Problem Description
It was reported that 1 day after implantation of an intraocular lens (iol) into the right eye (od), the patient present with blurry vision with best corrected distance visual acuity decreasing to 20/150 ph, thumbprint floater, 0.2mm hypopyon w/temporal fibrin, 3-5 + white cells, and robust inflammatory response continuing into the next day.On day 3 post-op, the patient complained of light sensitivity, seeing a checkered pattern, and white blobs with black worms everywhere with visual acuity further decreasing.Upon examination, the surgeon noted increased vitreous opacities and retinal hemorrhages and was referred for a vitreous tap & injections of 1mg vancomycin, 100mg ceftazidime, & 0.4mg dexamethasone were administered.Results of the culture & sensitivity were negative.Patient outcome is good.The following medications were prescribed for use at home post-operatively: moxifloxacin gtt 0.5% 3x 1 day (increased to aid) taper.Prednisolone gtt 1% 3x 1 day (increased q hour) taper.Prolensa gtt 0.07% 1 x day (increased qid) taper.Medrol pack 4 mg tab take as directed on pack.Durezol 0.05% 1 gtt q hr.

• 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: 21893664
• Report Number: 0001313525-2025-00071
• Device Sequence Number: 17026853
• Product Code: HQL
• UDI-Device Identifier: 10757770607928
• UDI-Public: (01)10757770607928(17)270831(11)240925(10)3Q26255
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: EEU2250
• Device Lot Number: 3Q26255
• 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: 03/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES96594
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC, ALCON BSS, B+L INJECTOR SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male