MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ASPIRE IOL; INTRAOCULAR LENS

Model Number	EA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day after implantation of an intraocular lens (iol) into the eye, the patient presented with increased blurry vision.Patient had about 3+ cell but no hypopyon.Topical steroids were increased and on the next day, the ac cell was slightly improved but vision was decreased with vitreous haze.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Intravitreal antibiotic injection were given.The patient is doing well and the vitreous haze resolved.Visual acuity correctable to 20/20.
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.

• Brand Name: ENVISTA ASPIRE IOL
• 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: 21894068
• Report Number: 0001313525-2025-00074
• Device Sequence Number: 14304189
• Product Code: HQL
• UDI-Device Identifier: 10757770608352
• UDI-Public: (01)10757770608352(17)271031(11)241127(10)3Q32507
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: User Facility,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: EA
• Device Catalogue Number: EAU1000
• Device Lot Number: 3Q32507
• 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: 03/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male