MAUDE Adverse Event Report: Bausch + Lomb EnVista SimplifEYE Injector; Folders and Injectors, Intraocular Lens (IOL)

Model Number	21987
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A legal protection agency reported that during implantation of an intraocular lens (iol) into the left eye, , a tear occurred at the inferotemporal edge of the capsulorhexis; the iol was therefore repositioned in the sulcus.The procedure was closed with buried corneal sutures and intracameral aprokam (cefuroxime).Approximately 10 days post procedure, the implanted iol subluxated inferotemporally.An iol exchange under general anesthesia was proposed and scheduled for approximately two months post procedure, however the patient declined further surgery.At follow-up visit 1 year and 4 months post procedure, the left eye showed a subluxated iol in the inferotemporal quadrant, superior corneal scar from 10 to 2 o'clock with four sutures in place, best corrected visual acuity 4/10 fluctuating (10/10 right eye) and iop 22 mmhg; fundus and macular oct normal, no corneal or macular oedema, no infection.
Additional Manufacturer Narrative
Additional information was requested but not received.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis , risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.

• Brand Name: EnVista SimplifEYE Injector
• Common Device Name: Folders and Injectors, Intraocular Lens (IOL)
• Manufacturer (Section D): Bausch + Lomb; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): Medicel AG; dornierstrasse 11; alternhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 50809511
• Report Number: 0001313525-2026-00145
• Device Sequence Number: 8900700
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 05/31/2026
• Device Model Number: 21987
• Device Lot Number: 2282B5
• 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: 07/27/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: enVista Intraocular Preloaded Toric
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male