MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.Microscopic examination found the lens cut in 2 pieces across the optic.A review of device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the left eye, the patient experienced constant temporal grey shadows, diagnosed as dysphotopsia.Approximately four months after implantation, the iol was exchanged with a different model iol.According to the surgeon, the most likely cause of the event is the patient needed a different style iol.Additional information was requested, but not received.* must request additional info/confirmation.
Additional Manufacturer Narrative
Additional information :a3a, b3, b5, b7, g3, h2.
Event or Problem Description
Additional information was received indicating that the negative dysphotopsia resolved and patient outcome is good.

• 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 habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 727724-6600
• MDR Report Key: 19817933
• Report Number: 0001313525-2024-00125
• Device Sequence Number: 18310491
• Product Code: HQL
• UDI-Device Identifier: 10757770531452
• UDI-Public: (01)10757770531452(17)261130(11)231213(10)3P33962
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: MXUE2350
• Device Lot Number: 3P33962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female