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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital reported that scratches were noticed on the intraocular lens (iol) after it was implanted in the eye.The iol was removed intraoperatively and replaced with another lens of the same power.The incision was enlarged to remove the iol and a suture was required.As a result of the increased duration of the surgery, an additional intracameral local anesthetic was necessary.There were no clinical consequences to the patient and the patient 's current condition is good.
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies 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 all 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 ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22383163
• Report Number: 0001313525-2025-00141
• Device Sequence Number: 17905861
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)261031(10)2304D8
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 2304D8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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 TORIC INTRAOCULAR LENS PRELOADED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown