MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	EE
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Swelling/ Edema (4577)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day after implantation of an intraocular lens (iol) in the right eye (od), the patient had cloudy vision and foreign body sensation in the operated eye.Per the surgeon the lens became dislocated.Two days postoperatively, a secondary procedure was performed to reposition the iol with no success.Approximately one week post original implant, the iol was removed and replaced with a different model lens.The patient subsequently experienced postoperative inflammation which was treated with steroid/antibiotics drops as expected and consistent with the standard course of multiple procedures.
Additional Manufacturer Narrative
The device was returned and evaluated.Evaluation found the lens returned in one piece with a long, wide and deep gouge mark in center of optic likely caused by an instrument during the iol removal process.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Additional information was received for this event.The patient is doing well on exam.The surgeon suspects fluid in eye is causing myopic shift.A yag pi is planned for aqueous misdirection syndrome.
Additional Manufacturer Narrative
Additional information b5,b6,d4,g3,h2,h4,h6,h10,h11.A review of the device history record (dhr) found no nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Although requested the facility will not be providing any further information.Based on the information provided, we are unable to determine a root cause.

• 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 INC.; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25414130
• Report Number: 0001313525-2026-00067
• Device Sequence Number: 13127844
• Product Code: HQL
• UDI-Device Identifier: 10757770607904
• UDI-Public: (01)10757770607904(17)280831(11)250810(10)3R24211
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: EE
• Device Catalogue Number: EEU2150
• Device Lot Number: 3R24211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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 Age: 67 YR
• Patient Sex: Unknown