MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the lens was not returned for evaluation.Additional information regarding the event was requested but not received.The device history record (dhr) review did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, a root cause could not be conclusively determined.
Event or Problem Description
It was reported that approximately 23 months after implantation of an intraocular lens (iol), the lens was explanted and replaced with a different model iol due to the initial iol becoming cloudy.Additional information was requested, but not received.
Additional Manufacturer Narrative
The lens was returned for evaluation.Microscopic examination found the lens cut in 2 pieces.One haptic is missing and was not found.Microscopic examination found the center of the optic white and has a cloudy ring appearance.The investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Based on the additional information received, the device causality was assessed as unrelated to the event, and therefore, this event no longer meets reportability requirements and is no longer deemed reportable.
Event or Problem Description
Additional information was received indicating the patient had pre-existing diabetic retinopathy.

• 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 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19070654
• Report Number: 0001313525-2024-00079
• Device Sequence Number: 6891455
• Product Code: HQL
• UDI-Device Identifier: 10757770531438
• UDI-Public: (01)10757770531438(17)240930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 03/12/2024

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 Expiration Date: 09/30/2024
• Device Model Number: MX60E
• Device Catalogue Number: MXUE2300
• Device Lot Number: 3167831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 06/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/10/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2021
• 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 Sex: Unknown