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	Retinal Tear (2050); Scar Tissue (2060); Visual Impairment (2138); Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional info: g3.Correction: h6.
Event or Problem Description
A consumer reported that after implantation of an intraocular lens (iol) in the right eye (od), they experienced fluid in the eye for approximately 4¿5 months.According to the consumer, the surgeon prescribed anti-inflammatory drops and the fluid subsequently resolved.Despite the reported resolution of the fluid, the consumer alleged they were unable to see distance and could only see near.The consumer stated that a laser procedure was performed approximately seven months post-operatively; however, distance vision did not improve following the procedure.The consumer further reported that the surgeon informed her that the reason for the ongoing visual issues was due to scar tissue formation in the eye from the prior fluid accumulation.Additional information was requested but not received.
Additional Manufacturer Narrative
The lens remains implanted.Additional information was requested but not received.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the information provided, a root cause of this event could not be determined.

• 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 pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 24257678
• Report Number: 0001313525-2026-00006
• Device Sequence Number: 8346276
• Product Code: HQL
• UDI-Device Identifier: 10757770608628
• UDI-Public: (01)10757770608628(17)280229(11)250316(10)3R06824
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: EA
• Device Catalogue Number: EAU2350
• Device Lot Number: 3R06824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2025
• 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 Sex: Female