MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported nine months after original implant of an intraocular lens (iol) into the eye, a lens exchange using a different model lens and diopter was completed due to persistent positive dysphotopsia.Dysphotopsia resolved with lens exchange and the patient's prognosis is excellent.In the surgeon's opinion, dysphotopsia is secondary to acrylic iol.It improved/resolved with exchange to silicone optic material.
Additional Manufacturer Narrative
Per the reporter, the device was discarded and not available for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the information provided, the most probable root cause is known procedure complication.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; 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: 19071616
• Report Number: 0001313525-2024-00080
• Device Sequence Number: 20004374
• Product Code: HQL
• UDI-Device Identifier: 10757770531513
• UDI-Public: (01)10757770531513(17)251031
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 10/31/2025
• Device Model Number: MX60
• Device Catalogue Number: MXUE2500
• Device Lot Number: 3270104
• 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
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2022
• 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