MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.The foreign material particulate issue is related to a component issue within the injector.Corrective measures have been initiated with the manufacturer of the injector to ensure proper monitoring and resolution.Bausch & lomb will continue to monitor similar events to determine if additional actions are required.
Event or Problem Description
The healthcare facility reported an ac washout (anterior chamber) was required two (2) months after an intraocular lens (iol) implantation.It was originally thought to be retained capsulorhexis at 3pm position, extending through ac close to endothelium.After assessment by the surgeon it was found to be of foreign body appearance.At follow-up one week post ac washout, the patient did not note any symptoms and was happy with the outcome.

• 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: 24912616
• Report Number: 0001313525-2026-00034
• Device Sequence Number: 15763460
• Product Code: HQL
• UDI-Device Identifier: 10757770531339
• UDI-Public: (01)10757770531339(17)280831(11)250906(10)3R23705
• Combination Product (Y/N): N
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: MX60E
• Device Catalogue Number: MXE2050
• Device Lot Number: 3R23705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROFLOW NDL., BIOJECT P220, LIGHT HANDLE COVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown