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

Model Number 21987

Device Problem Ejection Problem (4009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation.Visual examination was performed and the results found the iol stuck in the cartridge of the conical zone.The leading iol haptic is protruding from the tip of the inserter.Additional information has been requested for further clarification, but not received.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that after the placement of an intraocular lens (iol) into the eye, the iol was cut and removed from the eye due to haptic damage,.Allegedly from the lens ejecting at the left lateral position from the cartridge.An incision enlargement to remove the lens was made and sutures were used to close the incision.Additional information has been requested of the reporter, but not received.

Event Description

Additional information was received confirming the reported event and explant.

Manufacturer Narrative

Additional info: b5, g3, h2, h6, h10/11 the device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.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) might have 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 ; 7277246600
• MDR Report Key: 16967838
• MDR Text Key: 315639202
• Report Number: 0001313525-2023-70056
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)250630(10)21110A6
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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
• Device Lot Number: 21110A6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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: PROVISC VISCOELASTIC, ENVISTA IOL
• Patient Outcome(s): Required Intervention