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	Microcystic Edema (1823); Intraocular Pressure Increased (1937); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577)
Date of Event	03/11/2025
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 after implantation of an intraocular lens (iol) into the right eye (od), the patient presented the same day with moderate injection (diffuse), 2+ edema, severe diffuse superficial punctate keratitis (spk), 1+ flare, 1+cell.Based on the findings, the surgeon concluded the cause as toxic anterior segment syndrome (tass).In the surgeon's opinion, the most likely cause of the event is the iol.Patient outcome is good.Medications administered during original surgery: kenalog & moxifloxacin.The following medications were prescribed for use at home post-operatively: tylenol, prn.Prolensa 0.07%, 1 gtt qd 4 weeks.Difluprednate 0.05%, 1 gtt every hour.
Event or Problem Description
Additional information was received indicating that at the 1-day postoperative visit, the patient reported significant eye pain and presented with elevated intraocular pressure (iop), diffuse microcystic edema, 3-4+ anterior chamber cell and 3+ conjunctival injection.An anterior chamber paracentesis was performed.At the 1-month follow-up visit, iop was noted as stable.
Additional Manufacturer Narrative
Additional info: b4, b5, b6, b7, g3, h2, h6, 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 ; +1(727)724-6600
• MDR Report Key: 21903102
• Report Number: 0001313525-2025-00095
• Device Sequence Number: 17146084
• Product Code: HQL
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: EEU2000
• Device Lot Number: 3Q30527
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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 INJECTOR, AMVISC, CLEARVISC, B+L BSB500 BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male