MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an iol was explanted from a patient's eye due to patient's inability to adapt to the lens.The lens was replaced with a different model and the patient is reporting improved vision.Additional information was requested, but not received.
Additional Manufacturer Narrative
Although requested, additional information regarding the event was not provided and the lens was not returned for investigation.A device history record (dhr) review did not find any non-conformities or anomalies related to this event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the information provided, the root cause of this event could not be determined.
Additional Manufacturer Narrative
Based on the additional information received, the device causality was assessed unrelated to the event, and therefore, this event no longer meets reportability requirements and no longer deemed reportable.
Event or Problem Description
Additional information was received indicating a 3.5 diopter difference between the original and the replacement iol.Additionally, the replacement iol is reportedly toric.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 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: 18004626
• Report Number: 0001313525-2023-70116
• Device Sequence Number: 7604109
• Product Code: HQL
• UDI-Device Identifier: 10757770531292
• UDI-Public: (01)10757770531292(17)251031
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 10/31/2025
• Device Model Number: MX60E
• Device Catalogue Number: MXUE1950
• Device Lot Number: 3268904
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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