MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INSERTER; 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	Corneal Edema (1791)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.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, the root cause of this event could not be conclusively determined.
Event or Problem Description
It was reported that during implantation of an intraocular lens (iol), after inserting the iol, the surgeon noticed the iol optic was damaged.The incision was enlarged and an intraoperative lens exchange was performed using a backup iol.Corneal edema was reported.Additional information was requested, but not received.
Additional Manufacturer Narrative
The device was returned for evaluation.Microscopic examination found the shuttle attached correctly to the device.No damage was observed.
Event or Problem Description
Additional information was received indicating that the incision size was enlarged to 2.5mm, which is within standard range for incision enlargement.
Additional Manufacturer Narrative
Based on additional information received this event no longer meets reportability requirements and is no longer deemed reportable.

• 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; altenrheim CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19132853
• Report Number: 0001313525-2024-00087
• Device Sequence Number: 15178547
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)251130(10)2209C6
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2024

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: 11/30/2025
• Device Model Number: 21987
• Device Lot Number: 2209C6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/03/2024; 06/04/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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 TORIC IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown