MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.
Event or Problem Description
It was reported that after one day after implantation of an intraocular lens (iol) into the eye, the patient presented with intense inflammation and thick fibrotic tissue around the lens.The patient was referred to a retina specialist and treated with frequent steroids.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).In the surgeon¿s opinion, the most likely cause of the event is an atypical presentation of tass.Additional information was requested, but not received.
Additional Manufacturer Narrative
Updated b5, g3, h2, h6 and h11.The device was not returned.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.
Event or Problem Description
Additional information was received.The iol was explanted and another iol was implanted with sutures.Additional information was requested, but not received.
Event or Problem Description
Additional information was received.A lens of a different model was implanted.The patient has severe keratoconus and required corneal sutures as a result to close the incision properly.The tass has resolved after treatment.

• 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 ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21933846
• Report Number: 0001313525-2025-00105
• Device Sequence Number: 12988531
• Product Code: HQL
• UDI-Device Identifier: 10757770530967
• UDI-Public: (01)10757770530967(17)261130(11)231213(10)3P34022
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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: MX60E
• Device Catalogue Number: MXUE0100
• Device Lot Number: 3P34022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 06/27/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/17/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: 75 YR
• Patient Sex: Male