MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS

Model Number 21987

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Date 08/15/2022

Event Type  Injury  

Event Description

It was reported that an intraocular lens (iol) implanted into the right eye (od) was explanted approximately four (4) months after implant due to an optic scratch noticed postoperatively.The patient presented with a decrease in vision.A successful lens exchange was completed using the same model lens with a different diopter power.In the physician''s opinion, the most likely cause of the event was due to a loading error.The patient''s outcome is good.

Manufacturer Narrative

Though requested of the reporter, the device was not returned for evaluation.As the lot number is unknown, the associated device history record (dhr) was not reviewed.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, a root cause of the event could not be conclusively determined.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15420144
• MDR Text Key: 299882087
• Report Number: 0001313525-2022-00120
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2022

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
• Device Catalogue Number: 21987_B10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male