MAUDE Adverse Event Report: BAUSCH + LOMB INC. ENVISTA INTRAOCULAR LENS

Model Number	EEU
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that post iol (intraocular lens) surgery they developed glares and halos in the dark and experienced difficulty seeing their computer.The iol was explanted and replaced with a new one of an unknown model and power.The consumer confirmed their symptoms resolved.Additional information has been requested, but not received.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB INC.; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 6362263220
• MDR Report Key: 24321148
• Report Number: 0001313525-2026-00008
• Device Sequence Number: 13272115
• Product Code: HQL
• UDI-Device Identifier: 10757770607997
• UDI-Public: (01)10757770607997(17)271130(11)241213(10)3Q34131
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: EEU
• Device Catalogue Number: EEU2600
• Device Lot Number: 3Q34131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female