MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	EE
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Hypopyon (1913); Intraocular Pressure Increased (1937); Iritis (1940); Retinal Injury (2048); Visual Impairment (2138); Fibrosis (3167); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Photophobia (4801)
Date of Event	12/06/2024
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 eye, the patient was diagnosed with endophthalmitis.The surgeon stated the signs and symptoms seemed more consistent with toxic anterior segment syndrome (tass).Allegedly, the patient ended up losing vision and needing an additional surgery.Additional information was requested but not received.
Additional Manufacturer Narrative
Add info: a3a, b5, g3, h2, h6, h11.
Event or Problem Description
Additional information received indicated that on post-op day 1 the patient complained of spiking pain and light sensitivity.The patient presented with moderate corneal edema and at least 3+ cell in the anterior chamber.An anterior chamber paracentesis was performed, and the patient was prescribed simbrinza.Later that day the patient reported increasing pain, the surgeon prescribed methazolamide to be taken orally.The following day the patient presented with marked edema and a hypopyon.Based on the findings, the surgeon determined the cause of the event to be either tass (toxic anterior segment syndrome) or endophthalmitis.The patient was immediately referred to retina for a tap and inject to be performed.The tap did not yield any growth; therefore, the surgeon concluded the cause of the event to be tass.Approximately nine days later the patient underwent a vitrectomy with membrane stripping, ac washout, and kenalog.At one-month post-op patient presented with relative afferent pupillary defect (rapd), irregular iris, and some fibrosis over the lens implant.Patient's vision improved slightly to 20/100-2 (ph 20/60-) & intraocular pressure (iop) improved.The patient was lost to follow up for several months due to a having a stroke.At the most recent exam performed by implanting surgeon, the optical coherence tomography (oct) of the macula indicated permanent retinal damage.Vision had improved to 20/40, but no improvement with pinhole.The patient was most recently seen by a retina specialist who noted who noted chronic iritis and deposits on the iol.Patient is still under implanting surgeon's care and will follow up again in a couple months.
Event or Problem Description
Additional information was received indicating the eye has largely stabilized.The patient still has visual deficits in relation to the other healthy eye, but there is no longer active inflammation.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h11.

• 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: 21913482
• Report Number: 0001313525-2025-00103
• Device Sequence Number: 20649746
• Product Code: HQL
• UDI-Device Identifier: 10757770607850
• UDI-Public: (01)10757770607850(17)270831(11)240923(10)3Q25942
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2025

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: EEU1900
• Device Lot Number: 3Q25942
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 07/28/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male