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

Model Number 21987

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

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

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on all available information, the root cause cannot be conclusively determined.No corrective action is necessary at this time.

Event Description

The healthcare facility reported a damaged haptic during an intraocular lens (iol) implant.The incision was enlarged to remove the lens and no sutures were required.The procedure was completed with a replacement lens of the same model and diopter.Additional information has been requested.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection found that the shuttle was securely and correctly attached to the inserter.The plunger was in the advanced position and the plunger tip was protruding from the cartridge tip.The plunger tip top fork was broken and was missing.The lens was not inside the injector or returned otherwise.Due to the condition received, functional testing could not be performed.Our assessment of this event remains the same.

Event Description

Additional information was received indicating the event was associated with the fork of the inserter.Allegedly once it was pushed, it caused breakage of the iol.

Manufacturer Narrative

Additional investigation on the returned injector indicated a plunger fork damage which results when the plunger is not fully retracted and the plunger safety is not engaged and/or if the shuttle is not completely snapped into the injector.Based on the available information, unintended user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and injector interaction) may have contributed to the event.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 13051556
• MDR Text Key: 282551073
• Report Number: 0001313525-2021-00162
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K192005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2021

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 Expiration Date: 11/30/2023
• Device Model Number: 21987
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 03/14/2022; 03/14/2022
• Supplement Dates FDA Received: 04/04/2022; 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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 INTRAOCULAR LENS PRELOADED, PROVISC
• Patient Outcome(s): Required Intervention