MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INSERTER; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number	21987
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hospital confirmed the product is not available for evaluation.A review of device history record (dhr) did not identify any anomalies or non-conformities 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 is "design".
Event or Problem Description
It was reported that during implantation an adverse event occurred during surgery where the tip of an envista injector snapped inside the patient¿s eye.The patient required an enlarged incision (about 3.5 mm) and removal of the foreign body, followed by two stitches.The original lens remained in place prior to the injector tip snapping off, so that lens stayed in the eye.The surgeon's opinion attributes the issue to the envista injector.The patient has recovered.

• Brand Name: ENVISTA SIMPLIFEYE INSERTER
• 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 ; 7277246600
• MDR Report Key: 23742803
• Report Number: 0001313525-2025-00221
• Device Sequence Number: 15977619
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown