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	Corneal Edema (1791); Inflammation (1932); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that four days after implantation of an intraocular lens (iol) into the right eye, the patient presented with decreased vision and severe anterior chamber inflammation and systemic rash.Slit lamp findings were 3+ corneal edema, 2mm hypopyon and fibrin on iol.Patient's bcva decreased.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Patient was treated with intravitreal antibiotics and topical steroids.In the surgeon¿s opinion, the most likely cause of the event is tass or endophthalmitis.The patient is recovering and continues to make improvements in vision as corneal edema and vitritis improve.The following medications were prescribed (for use at home post-operatively): prednisolone and ofloxacin.
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.

• 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: 21895096
• Report Number: 0001313525-2025-00083
• Device Sequence Number: 3553077
• Product Code: HQL
• UDI-Device Identifier: 10757770607874
• UDI-Public: (01)10757770607874(17)271031(11)241127(10)3Q32509
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: EEU2000
• Device Lot Number: 3Q32509
• 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: 11/27/2024
• 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, BLIX-X1, AMVISC PLUS, ALCON BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female