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

Model Number	21987
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.A device history record review could not be completed as a lot number was not provided.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, a root cause could not be conclusively determined.
Event or Problem Description
Reportedly, during iol implant procedure the injector piston overrode the lens.The incision was enlarged to remove the iol and a back up lens of an unknown model was implanted.A corneal suture was required.Additional information has been requested but not received.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB INC.; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 18735495
• Report Number: 0001313525-2024-70044
• Device Sequence Number: 6234970
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)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
• 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): 08/29/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA PRELOADED TORIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown