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	Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577)
Date of Event	11/23/2024
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 three days after an implantation of an intraocular lens (iol) in the left eye, the patient was suspected of having toxic anterior segment syndrome (tass) or endophthalmitis.Slit lamp findings were 0.5mm hypopyon, 4+cell in ac, posterior vitreous quiet, corneal and epi-defect.A vitrectomy was performed and intraocular injections of antibiotics were administered.The patient's bcva decreased due to post-op swelling and reaction to tass.In the surgeon¿s opinion, the most likely cause of the event is tass or endophthalmitis.The patient's outcome is good.The following medications were prescribed (for use at home post-operatively): symbrenza, vigamox, prolensa, durezol and moxifloxacin were given postoperatively.
Additional Manufacturer Narrative
The device remains implanted.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.

• 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; 21 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21896620
• Report Number: 0001313525-2025-00087
• Device Sequence Number: 3531000
• Product Code: HQL
• UDI-Device Identifier: 10757770531513
• UDI-Public: (01)10757770531513(17)270331(11)240425(10)3Q10606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: MXUE2500
• Device Lot Number: 3Q10606
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCON (B)(6) INJECTOR, ALCON BSS, DISCOVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female