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 06/14/2022

Event Type  Injury  

Event Description

It was reported that after implantation of an intraocular lens (iol) into the right (od) eye, the patient presented with a decrease in vision and the iol appeared to be scratched.In the surgeon''s opinion, the most likely cause of the iol damage was due to a loading error.The surgeon referred the patient to a specialist and approximately three weeks after implant, a successful lens exchange took place.The patient's outcome is good.Additional information has been requested, but not received.

Manufacturer Narrative

Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.As a lot number for the device was not provided, the associated device history record 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, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.

• 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
• MDR Report Key: 15128353
• MDR Text Key: 296846029
• Report Number: 0001313525-2022-00098
• 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: 05/27/2022

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
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/29/2022
• 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: 62 YR
• Patient Sex: Male