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	Hernia (2240); Eye Pain (4467)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare facility reported that during an implantation of an intraocular lens (iol) one of the haptics tore off.The lens was removed and the backup iol was implanted.The patient is severely hyperopic and has a very narrow anterior chamber, making manipulation difficult from the point of view of the corneal endothelium, and the removal of the defective implant promoted an iris hernia.This required additional sedation (propofol) for patient pain and increased the operating time by about 15 minutes (enlargement of the main incision, cutting with offset scissors, removal of the segmented iol, reinjection of the backup iol, reintegration of the iris, injection of miostat (carbachol), and placement of a suture).The surgeon doesn¿t think there will be any consequences in terms of visual acuity.The after-effects should be limited to an iris scar, which is usually asymptomatic.
Additional Manufacturer Narrative
The injector was returned for evaluation.The injector was received with the shuttle assembly correctly attached.The lens was not in the cartridge.The shuttle assembly was removed/detached from the injector and dissembled for inspection.Further inspection revealed a lens fragment trapped in the lens path; this was confirmed as a haptic from a lens.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, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.

• 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: 24776696
• Report Number: 0001313525-2026-00023
• Device Sequence Number: 9904511
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)270331(11)231024(10)2315F11
• 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
• Report Date (Section B): 04/03/2026

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 Model Number: 21987
• Device Lot Number: 2315F11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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 Sex: Unknown