MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated.Crystal-like residues were seen on the posterior side of the iol.The trend analysis is considered acceptable with the product performing within anticipated rates.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
It was reported one day post implant of an intraocular lens (iol) into the left eye (os) in a combine cataract and migs procedure.The iol appeared to have drop like condensation on both the anterior and posterior surfaces, developing further opacifications on the posterior surface of the iol over the course of the first post-operative week.At three weeks post op, the patient's anterior chamber (ac) inflammation was resolved, but the patient was unhappy with the visual outcome stating it was foggy and glare inducing.A successful lens exchange was completed approximately six weeks post implant using a different model iol.The patient's outcome is fair and stable.Additional information was requested, but not received.
Additional Manufacturer Narrative
Additional information: g3, h2, h6, h11.Evaluation of device through optical inspection and other analytical methods did not confirm the presence of the reported deposits.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause could not be conclusively 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 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 20480704
• Report Number: 0001313525-2024-00163
• Device Sequence Number: 15520618
• Product Code: HQL
• UDI-Device Identifier: 10757770531353
• UDI-Public: (01)10757770531353(17)270430(11)240526(10)3Q14001
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: MXUE2100
• Device Lot Number: 3Q14001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2024
• 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: B&L INJECTOR, CLEARVISC, AMVISC, HYDRUS MICROSTENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male