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

Model Number	ETA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypopyon (1913); Visual Impairment (2138); Visual Disturbances (2140); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities 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.
Event or Problem Description
It was reported that 1 day after implantation of an intraocular lens (iol) into the left eye (os), the patient presented with moderate wound edema, 4+ cell, fibrin & hypopyon.Based on the findings, the surgeon concluded the cause as toxic anterior segment syndrome (tass).As a precaution, the patient was immediately referred to retina for a culture to be performed and intravitreal injections of vancomycin & ceftazidime to be administered.The following day the patient had an additional round of intravitreal injections of vancomycin & ceftazidime.There was no growth from the culture.The inflammation/tass has fully resolved.In the surgeon's opinion, the most likely cause of the event is the lens.According to the surgeon, patient outcome is good.According to the consumer, her distance vision is blurry.
Additional Manufacturer Narrative
Additional information: a2, b5, b6, e1, g3, h2, h6, h11.
Event or Problem Description
Additional information was received indicating the affected eye was right eye (od), not left eye (os), as previously reported.The consumer reported that as soon as the protective shield was removed post-op, they noticed blurry vision and saw some light on the side, with symptoms improving after a couple days.

• Brand Name: ENVISTA ASPIRE TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 22187346
• Report Number: 0001313525-2025-00127
• Device Sequence Number: 12904352
• Product Code: MJP
• UDI-Device Identifier: 10757770621528
• UDI-Public: (01)10757770621528(17)270430(11)240528(10)3Q14008
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: ETA
• Device Catalogue Number: ETAU150+260
• Device Lot Number: 3Q14008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female