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

Model Number 21987

Device Problem Ejection Problem (4009)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 335709644
• Report Number: 0001313525-2024-70044
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K192005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 21987
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA PRELOADED TORIC
• Patient Outcome(s): Required Intervention