MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS

Model Number	21987
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return.Investigation of the event is in progress.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
A hospital reported that on day 3, following an uncomplicated iol implantation the patient presented with normal vision and satisfactory parameters.The patient returned on day 5, due to experiencing visual disturbances and reduced vision, they were referred to a retinal surgeon.The retinal surgeon discovered an abnormal trace during the ultrasound examination.As the patient's vision worsened, a second surgery was performed to replace the iol.The original iol was explanted and a new monofocal lens was placed in the eye.The original lens was determined to be decentralized implant superiorly and the haptic was broken in the anterior chamber.Six days post revision va was 8/10 with significant astigmatism, corneal edema, and suture in place.Twelve days post revision va was 10/10 with significant astigmatism, reduced corneal edema, and suture was removed that day.
Additional Manufacturer Narrative
Additional info: d4, g3, g6, h4, h6, h11.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 and direction for use review were considered acceptable, with the product performing with anticipated rates.Based on the available information, the root cause could not be conclusively determined.
Additional Manufacturer Narrative
Updated b5, b6, g3, g6, h2, h6 and h11.
Event or Problem Description
Additional information was received.At approximately three (3) months post procedure persistent corneal edema was present with a decrease in corrected vision to 8/10 with monocular prescription.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; alternhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22294938
• Report Number: 0001313525-2025-00132
• Device Sequence Number: 18259605
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)261130(10)2304H10
• Combination Product (Y/N): N
• PMA/510(K) Number: K192005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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: 21987
• Device Lot Number: 2304H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 09/02/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/17/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA PRELOADED TORIC IOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female