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	Inflammation (1932); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Mydriasis (4856)
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 after implantation of an intraocular lens (iol) into the left eye, the patient presented with prolonged inflammation and atonic pupil.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Patient required a descemet membrane endothelial keratoplasty (dmek) and pupiloplasty surgery.Patient outcome was reported to be good, with their vision being 20/20 after the postop of their second procedure.
Additional Manufacturer Narrative
The device remains implanted.A review of the lot device history record (dhr) did not identify any anomalies or non-conformities 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.
Additional Manufacturer Narrative
Updated b5, g3, h2 and h6.
Event or Problem Description
The patient reported they had eye inflammation, a pupil that is non-reactive and they visited a hospital where they received brain scans.The implanting surgeon reported that the patient had an unexplained dilated pupil which later was tied to tass.The brain scans were done to rule out a nerve palsy.
Event or Problem Description
Additional information was received indicating that on postoperative day 1, mild corneal edema was noted on the left eye.On postoperative week 1, there was fixed dilated pupil (5mm) and corneal edema.Pre-op pupil size; 5 mm light; 3 mm dim, 6.5 mm dilated.Approximately two weeks post-op, findings were partial ptosis, dilated pupil, nerve palsy and lead edema.One week later, corneal edema improved however patient was still visually symptomatic.Six days later, dmek (for corneal decompensation and poor visual recovery) with pupilloplasty (for appearance of difference in pupil size due to nonreactive pupil) was performed.Iris atrophy intra-op was noticed with no synechiae.The patient recovered well.
Additional Manufacturer Narrative
Updated b5, b6, b7, g3, h2 and h6.

• 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, Inc; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 21898918
• Report Number: 0001313525-2025-00092
• Device Sequence Number: 3434315
• Product Code: HQL
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2026

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: EEU1450
• Device Lot Number: 3Q21819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 09/05/2025; 08/21/2026
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/17/2025; 09/24/2025; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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: BLIS-R1, BLIS-X, PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female